Browse Device Recalls

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

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DateProductReasonClassFirm
Nov 5, 2014 Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revacle... Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Di... Class II Gambro Renal Products Inc
Nov 4, 2014 STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD ... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRA... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRA... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD ... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Nov 4, 2014 Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor... Internal testing and investigation of the packaging revealed cracks and holes in primary packaging Class II Pulsion Medical Inc
Nov 4, 2014 STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD S... Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak i... Class II Advanced Sterilization Products
Oct 31, 2014 The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bi... Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenat... Class II Medtronic Perfusion Systems
Oct 31, 2014 UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary p... Packaging non-conformance related to the integrity of the sterile pouch seal. Class II US Endoscopy Group Inc
Oct 21, 2014 Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and RE... All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile... Class II Gyrus Acmi, Incorporated
Oct 15, 2014 AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS M... During routine periodic packaging testing, AMS identified that in simulated extreme shipping and ... Class II American Medical Systems, Inc.
Oct 15, 2014 AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF... During routine periodic packaging testing, AMS identified that in simulated extreme shipping and ... Class II American Medical Systems, Inc.
Oct 14, 2014 St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Mo... St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Re... Class II St Jude Medical
Oct 13, 2014 Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot ... Class II Medtronic Vascular
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for rei... The patient record peel-off label product code and size did not match the other labeling and actu... Class II Davol, Inc., Subs. C. R. Bard, 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 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 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 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 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 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 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 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 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 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 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 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 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 Labor & Delivery Pack, Catalog number 900-168. 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 Laparoscopy Pack, Catalog number 900-1176. 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 Tummy Tuck & Liposuction Pack, catalog #900-2661 Used by medical staff... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Carpal Tunnel Surgical Large Pack, Catalog # 900-742A Used by medical staf... Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie... Class I Customed, Inc
Oct 8, 2014 Neuro Spine Pack, Catalog number 900-1300 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 Retina Pack, Catalog number 900-1611. Used by medical staff to perform pat... Customed products are being recalled because of compromised sterility, not limited to potentially... Class I Customed, 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.