Browse Device Recalls

3,629 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,629 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 3,629 FDA device recalls, Class I.

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DateProductReasonClassFirm
Nov 11, 2014 ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use ... Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... Class I Heart Sync, Inc.
Nov 11, 2014 ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, ... Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED ... Class I Heart Sync, Inc.
Nov 6, 2014 ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPA... Philips Healthcare made changes to the design of the connection between multifunction electrodes ... Class I ConMed Corporation
Nov 6, 2014 MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY ... Philips Healthcare made changes to the design of the connection between multifunction electrodes ... Class I ConMed Corporation
Nov 6, 2014 CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, D... Philips Healthcare made changes to the design of the connection between multifunction electrodes ... Class I ConMed Corporation
Nov 6, 2014 ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COM... Philips Healthcare made changes to the design of the connection between multifunction electrodes ... Class I ConMed Corporation
Nov 6, 2014 ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- CO... Philips Healthcare made changes to the design of the connection between multifunction electrodes ... Class I ConMed Corporation
Nov 6, 2014 PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- C... Philips Healthcare made changes to the design of the connection between multifunction electrodes ... Class I ConMed Corporation
Nov 6, 2014 ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- CO... Philips Healthcare made changes to the design of the connection between multifunction electrodes ... Class I ConMed Corporation
Nov 6, 2014 ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPA... Philips Healthcare made changes to the design of the connection between multifunction electrodes ... Class I ConMed Corporation
Nov 6, 2014 CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direc... Philips Healthcare made changes to the design of the connection between multifunction electrodes ... Class I ConMed Corporation
Oct 23, 2014 Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: T... Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws... Class I Synthes (USA) Products LLC
Oct 17, 2014 Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Mater... An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Ne... Class I Siemens Healthcare Diagnostics, Inc.
Oct 17, 2014 Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapi... An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Ne... Class I Siemens Healthcare Diagnostics, Inc.
Oct 10, 2014 Gel-E Donut : 92025-A (Extra Small), 92025-B (Small), 92025-C (Medium) an... Mold on gel filled Gel-E and Squishon products Class I Philips Medical Systems, Inc.
Oct 8, 2014 Laparotomy Pack III (4), catalog #900-2492 Used by medical staff to perfor... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cesarean Pack, Catalog number 900-403. Used by medical staff to perform pa... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Pack, Catalog number 900-3178. Used by medical staff to perfor... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Femoral Pack, catalog #900-2164 Used by medical staff to perform patient c... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cysto Tur Pack, Catalog number 900-430 Used by medical staff to perform p... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Peri Gyn Pack, Catalog number 900-1091. Used by medical staff to perform p... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Lithotomy Pack, catalog #900-2167 Used by medical staff to perform patient... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 OB Pack, catalog #900-254 Used by medical staff to perform patient care pr... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 OB Pack, Catalog number 900-1717. Used by medical staff to perform patient... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 O.R. Towels, Catalog number 900-629. Used by medical staff to perform pati... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Endovenous Custom Pack, Catalog number 900-1937. Used by medical staff to ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Wound Closure Tray I, Catalog number 900-063. Used by medical staff to per... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Angiography Pack, Catalog number 900-1488. Used by medical staff to perfor... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Skin Staple Removal, Catalog number 900-782. Used by medical staff to perf... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Peri Gyn Pack, Catalog number 900-1061. Used by medical staff to perform p... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to pe... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform pat... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cysto Tur Pack, catalog #900-2899 Used by medical staff to perform patient... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack 1 (2 & 3), catalog #900-2490 Used by medical staff to ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Angiography Pack, Catalog number 900-2038. Used by medical staff to perfor... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 ACDF Pack, catalog #900-2917 Used by medical staff to perform patient care... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cesarean Pack, Catalog # 900-660 Used by medical staff to perform patient ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Urology Pack, Catalog # 900-868 Used by medical staff to perform patient c... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by med... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Hip Orthopedia Pack, Catalog number 900-1835. Used by medical staff to per... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Universal Drainage Tray, Catalog number 900-032. Used by medical staff to ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack, catalog #900-2516 Used by medical staff to perform patien... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient ... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Pery Gyn Pack, Catalog number 900-635. Used by medical staff to perform pa... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack, Catalog number 900-176. Used by medical staff to perform ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perf... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Open Heart Pack, catalog #900-2618 Used by medical staff to perform patien... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Minor Laceration Tray, Catalog number 900-1765. Used by medical staff to p... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc

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.