Browse Device Recalls
35,653 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,653 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 35,653 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 25, 2026 | FORWARD Gunshot Wound Kit; Model: AFT-GSW; | Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue a... | Class II | INTEGRATED MEDCRAFT LLC |
| Sep 23, 2026 | HexaVue Focus Integration System, a single, all-in-one system that handles op... | A software issue may result in unintended mismatch of patient information on manually printed ima... | Class II | Steris Corporation |
| Sep 21, 2026 | RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased ... | Class II | Steris Corporation |
| Sep 21, 2026 | RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117 | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased ... | Class II | Steris Corporation |
| Sep 21, 2026 | RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased ... | Class II | Steris Corporation |
| Sep 16, 2026 | TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Sep 16, 2026 | TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Sep 16, 2026 | Williams Cystoscopic Injection Needles, used for cystoscopic injection into t... | The female Luer lock adapter component in the affected device lots may not have been correctly se... | Class II | Cook Incorporated |
| Sep 16, 2026 | Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Sep 16, 2026 | TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506. | Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for ... | Class II | Howmedica Osteonics Corp. |
| Sep 14, 2026 | Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORA... | Potential issue involving motor shaft breakage combined with reduced performance of the Single Fa... | Class II | Baxter Healthcare Corporation |
| Sep 14, 2026 | NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I. | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sen... | Class II | NOXBOX LTD |
| Sep 11, 2026 | Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A | Discrepancy in the shelf-life of a component | Class II | Medline Industries, LP |
| Sep 10, 2026 | NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030; | Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX ... | Class II | Boston Scientific Corporation |
| Sep 9, 2026 | REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm | Due to labeling error, bone screws specified as fully threaded, are actually partially threaded s... | Class II | In2bones USA, LLC |
| Sep 8, 2026 | PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF... | Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packag... | Class II | Ethicon, LLC |
| Sep 8, 2026 | Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Cata... | Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploite... | Class II | Nihon Kohden America LLC |
| Sep 7, 2026 | Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H -... | Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated. | Class II | Healthmark Industries Co., Inc. |
| Sep 5, 2026 | IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5... | Following a Chromium-based web-browser, report and displayed images may not match. | Class II | INTELERAD MEDICAL SYSTEMS INCORPORATED |
| Sep 3, 2026 | Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog N... | The potential for the devices to be mislabeled with the incorrect length. | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) EAR, Medline product numb... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline P... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | 1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) ... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, ... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Produ... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medlin... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline p... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, M... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline ... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Nu... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, M... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 ... | Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when test... | Class II | Beckman Coulter Inc. |
| Sep 2, 2026 | DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, ... | Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testin... | Class II | Beckman Coulter Inc. |
| Sep 2, 2026 | Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-... | Compression bandage may be degraded, which may cause unwanted foreign material to be introduced i... | Class II | Safeguard US Operating LLC |
| Aug 31, 2026 | Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOP... | Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potentia... | Class II | Medline Industries, LP |
| Aug 31, 2026 | Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ... | Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potentia... | Class II | Medline Industries, LP |
| Aug 31, 2026 | Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI ... | Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potentia... | Class II | Medline Industries, LP |
| Aug 31, 2026 | Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLO... | Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potentia... | Class II | Medline Industries, LP |
| Aug 31, 2026 | Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY ... | Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potentia... | Class II | Medline Industries, LP |
| Aug 31, 2026 | Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOP... | Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potentia... | Class II | Medline Industries, LP |
| Aug 31, 2026 | VERIFY Biological Steam Test Pack Model/Catalog Number: S3069 | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007 | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Numb... | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number... | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Biological Steam Test Pack Model/Catalog Number: S3065 | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 28, 2026 | TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88; | Devices failed in process testing related to the amount of pull force it can sustain prior to the... | Class II | LeMaitre Vascular, Inc. |
| Aug 28, 2026 | Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Int... | A navigation system used to aid in selection and positioning of orthopedic implant system compone... | Class II | Intellijoint Surgical, Inc. |
| Aug 28, 2026 | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dS... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.