Browse Device Recalls

3,664 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,664 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 3,664 FDA device recalls, Class I.

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DateProductReasonClassFirm
Oct 8, 2014 Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Pack, Catalog number 900-484 Used by medical staff to perform... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Laparotomy Pack, Catalog number 900-149. 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 Laparotomy Basic Pack, Catalog number 900-547 Used by medical staff to pe... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Femoral Angiography Pack, Catalog number 900-796. Used by medical staff to... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Fanfold Drape, Catalog number 900-633. 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 Cystoscopy Pack III, catalog #900-2482 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 Total Hysterectomy, catalog #900-2415 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 Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Femoral Pack, Catalog number 900-164. Used by medical staff to perform pat... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Pack, Catalog number 900-1967. 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 Open Heart Tray, Catalog number 900-1196C 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 Premium OB Pack, Catalog number 900-1297. 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 Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to per... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical st... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Cesarean Pack, Catalog number 900-1689. 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 Uretheral Catheter Tray, Catalog number 900-278. 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 Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Use... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to pe... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff ... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 Laparoscopy Chole Pack, Catalog number 900-1688. 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 Surgical Pack, catalog #900-281A Used by medical staff to perfo... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Extremity PACK, catalog #900-2615 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 Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by med... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 8, 2014 C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perfo... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Liposuction Pack, catalog #900-2656 Used by medical staff to perform patie... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Cataract Pack, Catalog # 900-944 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 Wound Management Tray Ill, Catalog number 900-540. Used by medical staff t... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, Inc
Oct 1, 2014 Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien ... Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter... Class I Nellcor Puritan Bennett Inc. (dba Covidien LP)
Oct 1, 2014 Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in ... A software issue may lead to ventilator inoperative situations. Class I Nellcor Puritan Bennett Inc. (dba Covidien LP)
Sep 20, 2014 Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. ... TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be... Class I Trivascular, Inc
Sep 18, 2014 Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pr... Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Sep 18, 2014 Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation E... Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Sep 18, 2014 Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number:... Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Sep 18, 2014 MediChoice¿ Multifunction Electrode Part Number: MC171 OH Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Sep 18, 2014 Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Sep 18, 2014 Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number:... Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi... Class I Covidien LLC
Sep 17, 2014 Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Gene... A failure of a specific component may prevent the ventilators from operating on AC power or trans... Class I Respironics California Inc
Sep 17, 2014 Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is ... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific Specimen Transportation System. Product Usage: 10... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% ... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific Specimen Transportation System. 10% NBF is used t... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10%... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 17, 2014 Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10%... The affected lots could have NBF concentrations that are lower or higher than the desired specifi... Class I Richard-Allan Scientific Company
Sep 16, 2014 Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogen... Particulate matter found inside the fluid path. Class I Baxter Healthcare Corp
Sep 16, 2014 Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, ... Particulate matter found inside the fluid path. Class I Baxter Healthcare Corp
Sep 8, 2014 Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx ... The pediatric breathing circuits can crack prior to and during use. Class I Teleflex Medical
Aug 19, 2014 STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 C... ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly highe... Class I ICU Medical, 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.