Browse Device Recalls
3,096 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,096 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 3,096 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 20, 2014 | LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTIO... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) C... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 13, 2014 | Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonograph... | Sterility of the device may be compromised due to unsealed pouch | Class II | CooperSurgical, Inc. |
| May 8, 2014 | Anspach Pneumatic and Electric Motor Systems. Intended for cutting and sha... | Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) wh... | Class II | The Anspach Effort, Inc. |
| Apr 24, 2014 | DISP 9730951 STRL SPHERE, 5PK INSERT | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | PACK 9731975 TUMOR RESECTION AXIEM CR | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | BAG 9732315 MOUSE STERILE 15 PK | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | PIN, 9733235, 100MM, STERILE, PERC REF | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | PATIENT TRACKER 9733534XOM ENT 1PK | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | BIOPSY NEEDLE KIT, 9733068, PASSIVE | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | INST 9731132 KIT CR REF FRAME DRIVER 5PK | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | TUMOR RESECTION KIT 9733608 SKULL MOUNT | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | PIN, 9733236, 150MM, STERILE, PERC REF | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | TRAJ GUIDE KIT, 9733066, BIOPSY, INT | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | DISP 9730950 STRL SPHERE, 1 PK INSERT | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| Apr 24, 2014 | INSTRUMENT TRACKER 9733533XOM ENT 1PK | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there ... | Class II | Medtronic Navigation, Inc. |
| 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 |
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.