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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.