Browse Device Recalls

65 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 65 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 65 FDA device recalls.

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DateProductReasonClassFirm
Nov 3, 2014 GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer:... Bard Access Systems is recalling GuardIVa (Ref. No. FP23AD006) from lot ASXHT003 because they wer... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Aug 8, 2014 BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which co... Class II Bard Access Systems
Jun 24, 2014 Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits... Potential for inadvertent scalpel stick injury involving the safety scalpel. Class II Bard Access Systems
Apr 28, 2014 Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems O... Greatbatch identified that the documentation does not support the five-year shelf life of the Bar... Class II Greatbatch Medical
Feb 27, 2014 PowerPort Slim Implantable Port, indicated for patient therapies requiring re... Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, h... Class II Bard Access Systems
Dec 6, 2013 MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Pr... Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Cathet... Class II Bard Access Systems
Dec 6, 2013 Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone... Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Cathet... Class II Bard Access Systems
Jun 10, 2013 StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single U... BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices... Class II Bard Access Systems
Feb 21, 2013 Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff wit... Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 Frenc... Class II Bard Access Systems
Feb 21, 2013 Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff wi... Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 Frenc... Class II Bard Access Systems
Aug 7, 2012 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit con... Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters be... Class III Bard Access Systems

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.