Medical device recalls at US companies, last 30 days
Each row is a medical device recall the FDA posted in the last 30 days for a US company, with the firm, the product, the recall class and the reason FDA gives. FDA data through October 24, 2026.
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Medical device recalls the FDA posted in the last 30 days
One row is one recall event. One event can cover many products. Class I recalls come first, then Class II, then Class III. Click the recall number to open the FDA record. Look up the 510(k) behind a recalled device: how to search the FDA 510(k) database.
| Posted | Recall class | Firm | City, state | Product | Reason (FDA) | Root cause (FDA) | Status | FDA record |
|---|---|---|---|---|---|---|---|---|
| Oct 10, 2026 | Class I | Instrumentation Laboratory | Bedford, MA | HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic Platelet Factor 4 Radioimmunoassay (LCO) and 1 more product | Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. | Under Investigation by firm | Open, Classified Started Sep 3, 2026 | Z-0001-2027 K170854 |
| Oct 1, 2026 | Class I | Draeger, Inc. | Telford, PA | VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module. Attachment, Breathing, Positive End Expiratory Pressure (BYE) | Potential cracks in the hose, which could lead to leakage or the hose falling off. | Under Investigation by firm | Open, Classified Started Sep 3, 2026 | Z-3252-2026 K092029 |
| Oct 1, 2026 | Class I | Medline Industries, LP | Northfield, IL | Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT F/ MDR107003E MDR530094… Bed, Therapeutic, Ac-Powered, Adjustable Home-Use (LLI) and 1 more product | Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire. Additional products added… | Device Design | Open, Classified Started Aug 14, 2026 | Z-3227-2026 |
| Oct 15, 2026 | Class II | Beckman Coulter, Inc. | Miami, FL | DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513 Automated Urinalysis System (KQO) and 1 more product | The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance… | Component design/selection | Open, Classified Started Aug 12, 2026 | Z-0160-2027 K210127 K252580 K022774 |
| Oct 15, 2026 | Class II | Cook Incorporated | Bloomington, IN | Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26… Endoscopic Injection Needle, Gastroenterology-Urology (FBK) | The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include… | Under Investigation by firm | Open, Classified Started Sep 16, 2026 | Z-0163-2027 K171602 |
| Oct 15, 2026 | Class II | Healthmark Industries Co., Inc. | Fraser, MI | Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model… Instrument, Manual, Surgical, General Use (MDM) | Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated. | Labeling design | Open, Classified Started Sep 7, 2026 | Z-0188-2027 |
| Oct 15, 2026 | Class II | Howmedica Osteonics Corp. | Mahwah, NJ | TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506. Tray, Surgical, Instrument (FSM) and 3 more products | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining… | Labeling design | Open, Classified Started Sep 16, 2026 | Z-0164-2027 |
| Oct 15, 2026 | Class II | Medline Industries, LP | Northfield, IL | Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D Angiography/Angioplasty Kit (OEQ) and 11 more products | Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use. | Under Investigation by firm | Open, Classified Started Sep 2, 2026 | Z-0168-2027 |
| Oct 15, 2026 | Class II | Medline Industries, LP | Northfield, IL | Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638… Laparoscopy Kit (FDE) and 5 more products | Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures. | Process change control | Open, Classified Started Aug 31, 2026 | Z-0180-2027 |
| Oct 15, 2026 | Class II | Medline Industries, LP | Northfield, IL | Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A Tourniquet, Pneumatic (KCY) | Discrepancy in the shelf-life of a component | Labeling Change Control | Open, Classified Started Sep 11, 2026 | Z-0189-2027 |
| Oct 15, 2026 | Class II | Merit Medical Systems, Inc. | South Jordan, UT | Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only… Marker, Radiographic, Implantable (NEU) | The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use. | Process control | Open, Classified Started Aug 27, 2026 | Z-0187-2027 K252892 |
| Oct 15, 2026 | Class II | Microgenics Corporation | Fremont, CA | MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF: OPRO-101; MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control… Multi-Analyte Controls, All Kinds (Assayed) (JJY) | Vial-to-vial variability in MAS Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results. | Process change control | Open, Classified Started Aug 17, 2026 | Z-0159-2027 |
| Oct 14, 2026 | Class II | Ethicon, LLC | San Lorenzo, PR | PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (GAQ) | Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause… | Process control | Open, Classified Started Sep 8, 2026 | Z-0153-2027 K946173 |
| Oct 14, 2026 | Class II | In2bones USA, LLC | Cordova, TN | REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm Screw, Fixation, Bone (HWC) | Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws. | Error in labeling | Open, Classified Started Sep 9, 2026 | Z-0157-2027 K170518 |
| Oct 14, 2026 | Class II | Steris Corporation | Mentor, OH | RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 Accessories, Cleaning, For Endoscope (FEB) and 2 more products | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which… | Process change control | Open, Classified Started Sep 21, 2026 | Z-0154-2027 K082988 |
| Oct 14, 2026 | Class II | W L Gore & Associates, Inc. | Flagstaff, AZ | Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire… Stents, Drains And Dilators For The Biliary Ducts (FGE) | The potential for the devices to be mislabeled with the incorrect length. | Under Investigation by firm | Open, Classified Started Sep 3, 2026 | Z-0158-2027 K170740 |
| Oct 13, 2026 | Class II | Baxter Healthcare Corporation | Deerfield, IL | Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES, NATURAL Product… Lift, Patient, Non-Ac-Powered (FSA) | Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients are at some risk for… | Process control | Open, Classified Started Sep 14, 2026 | Z-0151-2027 |
| Oct 13, 2026 | Class II | BioFire Diagnostics, LLC | Salt Lake City, UT | Generic Name: FilmArray Pneumonia Panel Generic Name: FilmArray Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack)… Respiratory Panel (QDP) and 2 more products | Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results | Under Investigation by firm | Open, Classified Started Aug 12, 2026 | Z-0148-2027 K243222 |
| Oct 9, 2026 | Class II | Becton Dickinson & Co. | Sparks, MD | BD Phoenix Panel NMIC-312. Catalog Number: 449082. System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (LON) and 1 more product | Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature. | Under Investigation by firm | Open, Classified Started Aug 13, 2026 | Z-0139-2027 K181665 |
| Oct 9, 2026 | Class II | Boston Scientific Corporation | Marlborough, MA | NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030; Stents, Drains And Dilators For The Biliary Ducts (FGE) | Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration. | Under Investigation by firm | Open, Classified Started Sep 10, 2026 | Z-0143-2027 K223592 |
| Oct 9, 2026 | Class II | Cadwell Industries Inc | Kennewick, WA | Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical… Stimulator, Electrical, Evoked Response (GWF) | Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient. | Under Investigation by firm | Open, Classified Started Aug 18, 2026 | Z-0141-2027 K162199 |
| Oct 9, 2026 | Class II | Ferno-Washington Inc | Wilmington, OH | Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821 Stretcher, Wheeled (FPO) | Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced powered performance. Issue… | Software design | Open, Classified Started Apr 28, 2026 | Z-0145-2027 |
| Oct 9, 2026 | Class II | INTEGRATED MEDCRAFT LLC | East Hampton, CT | FORWARD Gunshot Wound Kit; Model: AFT-GSW; First Aid Kit Without Drug (OHO) | Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the… | Component change control | Open, Classified Started Sep 25, 2026 | Z-0147-2027 |
| Oct 9, 2026 | Class II | Jenavalve Technology Inc. | Irvine, CA | JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S Aortic Valve, Prosthesis, Percutaneously Delivered (NPT) and 2 more products | Delivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. | Nonconforming Material/Component | Open, Classified Started Jul 31, 2026 | Z-0134-2027 |
| Oct 9, 2026 | Class II | Medtronic Sofamor Danek USA Inc | Memphis, TN | Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft… Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) (MBP) and 1 more product | Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product… | Process change control | Open, Classified Started Aug 12, 2026 | Z-0137-2027 K042707 K043048 K051188 |
| Oct 9, 2026 | Class II | Neuronetics, Inc. | Malvern, PA | NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1… Transcranial Magnetic Stimulator (OBP) | Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly. | Nonconforming Material/Component | Open, Classified Started Aug 24, 2026 | Z-0142-2027 K231926 K233621 |
| Oct 9, 2026 | Class II | Sarnova HC, Llc | Dublin, OH | Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Number 670272-KIT Support, Patient Position (CCX) | Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal cannula. | Nonconforming Material/Component | Open, Classified Started Jun 12, 2026 | Z-0144-2027 |
| Oct 9, 2026 | Class II | SI-BONE, Inc. | Santa Clara, CA | iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm) Sacroiliac Joint Fixation (OUR) | The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured. | Packaging | Open, Classified Started Aug 21, 2026 | Z-0146-2027 K203247 |
| Oct 7, 2026 | Class II | AVID Medical, Inc. | Toano, VA | DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28; General Surgery Tray (LRO) and 14 more products | Product may be potentially contaminated with a lubricant used during the manufacturing process. | Process change control | Open, Classified Started Aug 10, 2026 | Z-0092-2027 |
| Oct 7, 2026 | Class II | Canon Medical System, USA, INC. | Tustin, CA | Alphenix INFX-8000C/B5 Interventional Fluoroscopic X-Ray System (OWB) | Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error | Process control | Open, Classified Started Aug 26, 2026 | Z-0108-2027 K210900 |
| Oct 7, 2026 | Class II | LeMaitre Vascular, Inc. | Burlington, MA | TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88; Catheter, Embolectomy (DXE) | Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. | Under Investigation by firm | Open, Classified Started Aug 28, 2026 | Z-0117-2027 K022145 |
| Oct 7, 2026 | Class II | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC | Cortlandt Manor, NY | SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000; Test, Erythrocyte Sedimentation Rate (JPH) | During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of… | Process control | Open, Classified Started Aug 25, 2026 | Z-0107-2027 K840500 |
| Oct 7, 2026 | Class II | Steris Corporation | Mentor, OH | HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control… Light, Surgical, Accessories (FTA) | A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical… | Software design | Open, Classified Started Sep 23, 2026 | Z-0118-2027 |
| Oct 6, 2026 | Class II | Nihon Kohden America LLC | Irvine, CA | Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05… Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) | Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms. | Software design | Open, Classified Started Sep 8, 2026 | Z-0089-2027 K102376 |
| Oct 6, 2026 | Class II | Onkos Surgical, Inc. | Parsippany, NJ | Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (LPH) and 1 more product | Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. | Labeling mix-ups | Open, Classified Started Jul 24, 2026 | Z-0090-2027 K212815 K223348 |
| Oct 5, 2026 | Class II | Medline Industries, LP | Northfield, IL | Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support… Walker, Mechanical (ITJ) and 1 more product | The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If… | Process control | Open, Classified Started Aug 14, 2026 | Z-0086-2027 |
| Oct 5, 2026 | Class II | Medtronic MiniMed, Inc. | Northridge, CA | Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an… Alternate Controller Enabled Insulin Infusion Pump (QFG) | Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed… | Under Investigation by firm | Open, Classified Started Aug 20, 2026 | Z-0088-2027 K253743 |
| Oct 5, 2026 | Class II | Stryker Sustainability Solutions | Tempe, AZ | BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007 Catheter, Recording, Electrode, Reprocessed (NLH) | Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate… | Packaging process control | Open, Classified Started Aug 18, 2026 | Z-0085-2027 K030187 |
| Oct 2, 2026 | Class II | Beckman Coulter Inc. | Brea, CA | DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module… Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) and 1 more product | Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent… | Software design | Open, Classified Started Sep 2, 2026 | Z-0083-2027 K242190 K220977 |
| Oct 2, 2026 | Class II | Cardinal Health 200, LLC | Waukegan, IL | Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit… Tray, Surgical (LRP) | Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue… | Nonconforming Material/Component | Open, Classified Started Aug 19, 2026 | Z-0079-2027 |
| Oct 2, 2026 | Class II | DRG International, Inc. | Springfield, NJ | Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test); Sperm, Antigen, Antiserum, Control (DFQ) | Potential for false negative patient results. | Reprocessing Controls | Open, Classified Started Jul 2, 2026 | Z-0082-2027 |
| Oct 2, 2026 | Class II | Limitless Cryo Spa LLC | Ocean, NJ | Glypto Device, Glypto Cryo Machine; Unit, Cryosurgical, Accessories (GEH) | Lack of 510(k) clearance. | Under Investigation by firm | Open, Classified Started Aug 24, 2026 | Z-0080-2027 |
| Oct 2, 2026 | Class II | PHILIPS MEDICAL SYSTEMS | Cambridge, MA | Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside… System, X-Ray, Tomography, Computed (JAK) | Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion. | Under Investigation by firm | Open, Classified Started Aug 21, 2026 | Z-0078-2027 K244008 |
| Oct 2, 2026 | Class II | QUANTUM OPS Inc | Chattanooga, TN | Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patient positioner Model/Catalog Number: 804-33-300 (Enovis); 3105-400-030 (Stryker)… Table And Attachments, Operating-Room (BWN) | Due to a manufacturing issue (inadequate weld) for patient head positioning system. | Device Design | Open, Classified Started Jul 24, 2026 | Z-0076-2027 |
| Oct 2, 2026 | Class II | Safeguard US Operating LLC | Huntersville, NC | Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive… Dressing, Compression (MHW) | Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection. | Component change control | Open, Classified Started Sep 2, 2026 | Z-0081-2027 |
| Oct 2, 2026 | Class II | Steris Corporation | Mentor, OH | VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 Indicator, Biological Sterilization Process (FRC) and 5 more products | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no… | Under Investigation by firm | Open, Classified Started Aug 31, 2026 | Z-0070-2027 K854902 K083665 |
| Oct 1, 2026 | Class II | ASP Global, LLC. | Austell, GA | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Version: Not Applicable… Tourniquet, Pneumatic (KCY) and 63 more products | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years. | Under Investigation by firm | Open, Classified Started Aug 24, 2026 | Z-0003-2027 |
| Oct 1, 2026 | Class II | Custom Interventional Pain Management, LLC | San Antonio, TX | Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog Number: 24161B… Epidural Anesthesia Kit (OGE) | Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits. | Process control | Open, Classified Started Jan 15, 2026 | Z-0067-2027 |
| Oct 1, 2026 | Class II | Illumina, Inc. | San Diego, CA | NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130 High Throughput Dna Sequence Analyzer (PFF) | Retrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro diagnostic assays has a server with a security vulnerability. | Software design | Open, Classified Started Sep 17, 2024 | Z-0068-2027 |
| Oct 1, 2026 | Class II | Karl Storz Endoscopy | El Segundo, CA | HOPKINS Telescope 30, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS and HOPKINS II telescopes are to be used for visualization of the surgical… Nasopharyngoscope (Flexible Or Rigid) (EOB) | Due to incorrect inside packaging label for eyepiece. | Employee error | Open, Classified Started Aug 12, 2026 | Z-3333-2026 K945788 |
| Oct 1, 2026 | Class II | Siemens Healthcare Diagnostics, Inc. | Tarrytown, NY | Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223; System, Test, C-Reactive Protein (DCN) | The potential for falsely elevated results. | Under Investigation by firm | Open, Classified Started Aug 17, 2026 | Z-3335-2026 K221119 |
| Oct 1, 2026 | Class II | Wright Medical Technology, Inc. | arlington, TN | CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System Plate, Fixation, Bone (HRS) | Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal… | Process control | Open, Classified Started Aug 18, 2026 | Z-3334-2026 K133715 |
| Sep 29, 2026 | Class II | Olympus Corporation of the Americas | Center Valley, PA | Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction wtih OLYSENSE Hub System | While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable. | Under Investigation by firm | Open, Classified Started Aug 27, 2026 | Z-3329-2026 |
| Sep 29, 2026 | Class II | Penumbra Inc. | Penumbra Alameda, CA | Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT… Catheter, Thrombus Retriever (NRY) | Due to manufacturing issues reperfusion catheters may fracture. | Under Investigation by firm | Open, Classified Started Jul 24, 2026 | Z-3331-2026 K203440 K250690 |
| Sep 29, 2026 | Class II | Philips North America Llc | Cambridge, MA | Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333 System, X-Ray, Tomography, Computed (JAK) | The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation. | Radiation Control for Health and Safety Act | Open, Classified Started Aug 18, 2026 | Z-3155-2026 K244008 |
| Sep 29, 2026 | Class II | Tandem Diabetes Care, Inc. | San Diego, CA | Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS… Alternate Controller Enabled Insulin Infusion Pump (QFG) | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM)… | Software Design Change | Open, Classified Started Jul 16, 2026 | Z-3330-2026 K201214 K203234 K232380 |
| Sep 28, 2026 | Class II | Micro Therapeutics, Inc. | Irvine, CA | Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield… Intracranial Aneurysm Flow Diverter (OUT) | Due to incorrect label/product dimensions. Product is supposed to be 3.00 mm in diameter, but unit is packaging was a 2.50 mm in diameter. | Under Investigation by firm | Open, Classified Started Jun 25, 2026 | Z-3326-2026 |
| Sep 28, 2026 | Class II | Percussionaire Corporation | Sandpoint, ID | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with… Device, Positive Pressure Breathing, Intermittent (NHJ) and 6 more products | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter… | Device Design | Open, Classified Started Aug 18, 2026 | Z-3319-2026 |
| Sep 25, 2026 | Class II | Alere San Diego, Inc. | San Diego, CA | McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fisher Scientific… Visual, Pregnancy Hcg, Prescription Use (JHI) and 3 more products | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. | Device Design | Open, Classified Started Aug 20, 2026 | Z-3271-2026 K062361 K993065 K993203 |
| Sep 25, 2026 | Class II | American Contract Systems Inc | Tiffin, OH | Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO Laparoscopy Kit (FDE) and 2 more products | Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin… | Under Investigation by firm | Open, Classified Started Aug 10, 2026 | Z-3292-2026 |
| Sep 25, 2026 | Class II | American Nitrile Operations Llc | Grove City, OH | Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile… Polymer Patient Examination Glove (LZA) and 2 more products | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to… | Process control | Open, Classified Started Aug 14, 2026 | Z-3289-2026 K220825 |
| Sep 25, 2026 | Class II | Bard Peripheral Vascular Inc | Tempe, AZ | EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software Instrument, Biopsy (KNW) | Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and… | Software design | Open, Classified Started Aug 20, 2026 | Z-3275-2026 K252681 |
| Sep 25, 2026 | Class II | Cardinal Health 200, LLC | Waukegan, IL | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number… General Surgery Tray (LRO) and 3 more products | The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the… | Under Investigation by firm | Open, Classified Started Aug 18, 2026 | Z-3295-2026 |
| Sep 25, 2026 | Class II | Merit Medical Systems, Inc. | South Jordan, UT | Embosphere 500-700 micrometer 2 mL Syringe Sterile Steam, REF: S420GH/EUA, S620GH/EUA; Embosphere 700-900 micrometer 2 mL Syringe Sterile Steam, REF… Device, Vascular, For Promoting Embolization (KRD) | Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection. | Process control | Open, Classified Started Aug 10, 2026 | Z-3305-2026 K181300 |
| Sep 25, 2026 | Class II | Olympus Corporation of the Americas | Center Valley, PA | Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A. Hysteroscope (And Accessories) (HIH) and 1 more product | There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert. | Process control | Open, Classified Started Aug 24, 2026 | Z-3299-2026 K890328 |
| Sep 25, 2026 | Class II | Philips North America | Cambridge, MA | Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13; System, Nuclear Magnetic Resonance Imaging (LNH) and 11 more products | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party… | Software design | Open, Classified Started Aug 28, 2026 | Z-3307-2026 K223458 K251397 K183063 |
| Sep 25, 2026 | Class II | Volcano Corp | San Diego, CA | Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA System, Imaging, Pulsed Echo, Ultrasonic (IYO) | Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment. | Software Design Change | Open, Classified Started Aug 6, 2026 | Z-3276-2026 K253714 |
| Oct 15, 2026 | Class III | Magellan Diagnostics, Inc. | North Billerica, MA | LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762. Lead, Atomic Absorption (DOF) | In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and… | Labeling Change Control | Open, Classified Started Sep 4, 2026 | Z-0162-2027 K052549 |
| Oct 7, 2026 | Class III | Mindray DS USA, Inc. | Mahwah, NJ | ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) and 7 more products | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions | Labeling design | Open, Classified Started Aug 31, 2026 | Z-0109-2027 K260098 K213799 K242728 |
| Oct 2, 2026 | Class III | Medical Action Industries, Inc. 306 | Arden, NC | Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software… Urine Collection Kit (Excludes Hiv Testing) (OIE) | An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027. | Labeling design | Open, Classified Started Jul 9, 2026 | Z-0069-2027 |
| Oct 22, 2026 | Class not yet posted | AVID Medical, Inc. | Toano, VA | Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31. General Surgery Tray (LRO) and 1 more product | A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications. | Process control | Open, Classified Started Sep 8, 2026 | Z-0282-2027 |
| Oct 22, 2026 | Class not yet posted | CooperVision, Inc. | West Henrietta, NY | Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables Advanced Toric… Lenses, Soft Contact, Daily Wear (LPL) | The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have… | Labeling design | Open, Classified Started Sep 22, 2026 | Z-0204-2027 K160803 K213164 K220070 |
| Oct 22, 2026 | Class not yet posted | Medline Industries, LP | Northfield, IL | MEDLINE DRAPE C-SECTION W/POUCH ST 7/CS, Medline Product Number/SKU DYNJP6101 Drape, Surgical, Exempt (PUI) and 12 more products | Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin. | Under Investigation by firm | Open, Classified Started Sep 9, 2026 | Z-0269-2027 |
| Oct 22, 2026 | Class not yet posted | Medtronic MiniMed, Inc. | Northridge, CA | Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1… Calculator, Drug Dose (NDC) | A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating their app to version… | Software design | Open, Classified Started Sep 2, 2026 | Z-0265-2027 K253512 |
| Oct 22, 2026 | Class not yet posted | Medtronic Neuromodulation | Minneapolis, MN | InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO 33CM SSMRI TINED 978A133 LEAD 978A141 ISTM… Implanted Electrical Device Intended For Treatment Of Fecal Incontinence (QON) and 1 more product | Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product. | Under Investigation by firm | Open, Classified Started Sep 8, 2026 | Z-0266-2027 |
| Oct 22, 2026 | Class not yet posted | restor3d Inc. | Durham, NC | Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description: The restor3d… Prosthesis, Toe, Hemi-, Phalangeal (KWD) | Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization. | Process change control | Open, Classified Started Sep 4, 2026 | Z-0264-2027 K201393 |
| Oct 22, 2026 | Class not yet posted | Solstice Corporation | South Portland, ME | Xact mole marker for mammography Model/Catalog Number: M15RM System, X-Ray, Film Marking, Radiographic (JAC) | The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material. | Process control | Open, Classified Started Sep 22, 2026 | Z-0268-2027 |
| Oct 21, 2026 | Class not yet posted | Beckman Coulter, Inc. | Indianapolis, IN | ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima… Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (JQC) and 1 more product | Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of samples being processed. When used for in… | Nonconforming Material/Component | Open, Classified Started Sep 21, 2026 | Z-0201-2027 |
| Oct 21, 2026 | Class not yet posted | Greiner Bio-One North America, Inc. | Monroe, NC | Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with… Tubes, Vials, Systems, Serum Separators, Blood Collection (JKA) | Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause… | Nonconforming Material/Component | Open, Classified Started Jul 29, 2026 | Z-0200-2027 K960857 |
| Oct 21, 2026 | Class not yet posted | Medtronic MiniMed, Inc. | Northridge, CA | CareLink Clinic, REF: MMT-7350 Continuous Glucose Monitor Retrospective Data Analysis Software (PHV) | CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or… | Software design | Open, Classified Started Sep 11, 2026 | Z-0203-2027 |
| Oct 20, 2026 | Class not yet posted | Ventec Life Systems, Inc. | Bothell, WA | VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support. Ventilator, Continuous, Facility Use (CBK) and 11 more products | Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy. | Under Investigation by firm | Open, Classified Started Sep 17, 2026 | Z-0122-2027 K162877 |
| Oct 16, 2026 | Class not yet posted | Abbott | Plymouth, MN | Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-018 3. 9-ACP2-007-020 4. 9-ACP2-007-022 5. 9-ACP2-010-025 6… System, Appendage Closure, Left Atrial (NGV) | Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI). | Labeling design | Open, Classified Started Sep 10, 2026 | Z-0191-2027 |
| Oct 16, 2026 | Class not yet posted | Axonics, Inc. | Irvine, CA | PNE Lead Implant Kit REF: 1701 Stimulator, Electrical, Implantable, For Incontinence (EZW) | Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users. | Component change control | Open, Classified Started Jul 15, 2024 | Z-0198-2027 |
| Oct 16, 2026 | Class not yet posted | B Braun Medical Inc | Bethlehem, PA | B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068. Set, Administration, Intravascular (FPA) | Potential for leakage and backflow at the Safsite valve. | Process control | Open, Classified Started Sep 14, 2026 | Z-0193-2027 K942988 |
| Oct 16, 2026 | Class not yet posted | Medtronic Navigation, Inc. | Lafayette, CO | Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly Neurological Stereotaxic Instrument (HAW) and 3 more products | Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres. | Under Investigation by firm | Open, Classified Started Aug 31, 2026 | Z-0194-2027 K033621 K971247 |
| Oct 16, 2026 | Class not yet posted | Philips North America | Cambridge, MA | Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) | Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central monitoring system (PIC iX). | Software design | Open, Classified Started Sep 16, 2026 | Z-0199-2027 |
| Oct 16, 2026 | Class not yet posted | Philips Ultrasound, LLC | Bothell, WA | Philips Lumify Diagnostic Ultrasound System System, Imaging, Pulsed Doppler, Ultrasonic (IYN) | Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambulances/aircraft/field); 2) At connection… | Device Design | Open, Classified Started Sep 24, 2026 | Z-0152-2027 K242519 K242670 |
| Oct 16, 2026 | Class not yet posted | Think Surgical, Inc. | Fremont, CA | Think Surgical Square Driver REF: 109126 Orthopedic Stereotaxic Instrument (OLO) | Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling. | Process control | Open, Classified Started Aug 20, 2026 | Z-0192-2027 K261024 |
Source: FDA public records, from openFDA's device recall and enforcement data (api.fda.gov), last updated October 24, 2026. A recall is an action the firm takes; the FDA posts it and assigns its class. "Class not yet posted" means the FDA has not posted the class yet. Each row links to the FDA record, which has the full details. Whimbrel shows US firms only and leaves out the names, phone numbers and emails of people that appear in FDA records.
What a medical device recall is
A recall is an action a firm takes to fix or remove a device that has a problem. The firm may fix the device where it is used, change the labels, or take the device back. The FDA posts each recall and gives it a class. The class shows how serious the health risk is. Source: FDA, Medical Device Recalls.
Search the FDA recall database for medical devices
- Open the FDA medical device recall database.
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The FDA recall database goes back many years. This page shows the last 30 days only, for US firms.
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