Browse Device Recalls

3,164 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,164 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 3,164 FDA device recalls.

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DateProductReasonClassFirm
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
Jul 22, 2013 Contra-Angle Torque Driver Kit For Certain and External Connection Product... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usa... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Navigator Surgical Kit Product Usage: Molded plastic tray used in holding... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 22, 2013 Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray... During recent revised sterilization validation testing, the included surgical trays did not meet ... Class II Biomet 3i, LLC
Jul 18, 2013 Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Late... Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sa... Class II Aspen Surgical Products, Inc.
Jun 24, 2013 SC2316, Distal Femoral Augment with Screw Total knee replacement due to os... The firm became aware of an incident relating to a breach of sterility in the sterility barrier p... Class II Stelkast Co
Jun 19, 2013 VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 m... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 Free Lock Femoral Hip Fixation System Compression Tube/Plate, different lengt... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
Jun 19, 2013 VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor... Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t... Class II Zimmer, Inc.
May 31, 2013 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUS... Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the... Class II Karl Storz Endoscopy America Inc
May 24, 2013 GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 13071... lack of sterility assurance Class II Gyrus Acmi, Incorporated
May 6, 2013 Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachm... Product did not reach expected sterility assurance level Class II The Anspach Effort, 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.