Browse Device Recalls

3,179 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,179 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 3,179 FDA device recalls.

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DateProductReasonClassFirm
Apr 24, 2014 SHUNT KIT 9733605 NON-INVASIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TUMOR RESECTION KIT 9733607 NON-INVASIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 SPHERES 8801075 5/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 BIT 9733516 2.9mm DRILL STERILE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TRAJ GUIDE KIT, 9733065, BIOPSY, EXT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 SPHERES 8801071 1/TRAY 12PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 MOUSE 9732721 STERILE O-ARM 10PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 ENT PRGM 9734636 ADD FUSION NAV AxiEM Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 KIT, 9731427, THORACIC TACTILE PROBES Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 TUMOR RES. PACK 9733553 AxiEM S.M. Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 DRAPE 9732722 TUBE STERILE O-ARM 20PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Apr 24, 2014 UPGRD PRGM 9734638 ADD AxiEM NAVIGATION Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... Class II Medtronic Navigation, Inc.
Mar 4, 2014 Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800... Sterility of the product cannot be guaranteed. Class II Teleflex Medical
Mar 3, 2014 Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 3... The sterile pouch of the devices from this lot may not be completely sealed and sterility may be ... Class II Boston Scientific Corporation
Feb 19, 2014 Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon I... The possibility exists that an incomplete seal on the packaging compromised the sterility of the ... Class II Ethicon, Inc.
Feb 19, 2014 Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and R... Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, ... Class II Gyrus Medical, Inc
Jan 31, 2014 Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T1028... Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Imp... Class I Greatbatch Medical
Dec 19, 2013 Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with S... Sterility cannot be guaranteed. Class II Teleflex Medical
Dec 19, 2013 Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with S... Sterility cannot be guaranteed. Class II Teleflex Medical
Dec 12, 2013 VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, St... Sterility of medical devices intended for use in surgical procedures may be compromised. Class II Terumo Cardiovascular Systems Corporation
Nov 26, 2013 BD Interlink threaded lock cannula This is a locking blunt plastic cannula s... BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the pote... Class II Becton Dickinson & Company
Nov 20, 2013 TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Univ... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Unive... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Univ... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Unive... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Inte... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 20, 2013 TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Univ... Sterility of device may be compromised due to lack of pouch seal integrity Class II Boston Scientific Corporation
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable S... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable S... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Oct 18, 2013 Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Cat... Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) C... Class II Stryker Sustainability Solutions
Oct 3, 2013 STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product cod... Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not ... Class III Advanced Sterilization Products
Aug 28, 2013 Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse ... The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured. Class II Globus Medical, Inc.
Aug 12, 2013 Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed i... A medical device used in surgical procedures was packaged in a pouch in which a defective seal ma... Class II MicroAire Surgical Instruments, LLC
Aug 12, 2013 Steinmann Pin, packed in a clear tube with end caps, tubes packed in a steril... A medical device used in surgical procedures was packaged in a pouch in which a defective seal ma... Class II MicroAire Surgical Instruments, LLC
Jul 31, 2013 "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors ... The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance ... Class II Edwards Lifesciences, LLC
Jul 26, 2013 Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 ... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 i... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 i... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. S... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. ... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 26, 2013 Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in.... This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm ... Class II ASO, LLC
Jul 24, 2013 Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 083104... Nestle HealthCare Nutrition, Inc. is initiating a recall on some of Compat NG Tubes because they... Class II Nestle HealthCare Nutrition

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.