Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
May 12, 2015 ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog n... A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part... Class II Stryker Howmedica Osteonics Corp.
May 8, 2015 Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Sur... Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the ... Class II Ethicon, Inc.
May 6, 2015 VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique... The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank lab... Class III ORTHO-CLINICAL DIAGNOSTICS
May 6, 2015 IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (... IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to s... Class II Siemens Healthcare Diagnostics, Inc.
May 4, 2015 Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhyt... Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 28... Class II Spine Wave, Inc.
May 1, 2015 Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 ... Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Nee... Class II Integra LifeSciences Corp. d.b.a. Integra Pain ...
Apr 27, 2015 0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, ... Incorrect expiration date on label Class II MRP, LLC dba AMUSA
Apr 27, 2015 Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon C... One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrec... Class II Boston Scientific Corporation
Apr 22, 2015 regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit ... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800569, Sterile, CV0659 - Open Heart A & B - surgical kit... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit cont... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit con... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number 800567001, Sterile, GY0656A - Robotic Hysterectomy - surg... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical ki... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800525, Sterile, OR0609 - Extremity Pack - surgical kit c... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy Pk - surgical k... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800528, Sterile, GS0612 - Lap Chole Pk - surgical kit co... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800546, Sterile, GS0635 - Abdominal - surgical kit contai... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800560001, Sterile, GS0649A - Lap Chole - surgical kit co... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - surgical k... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800524, Sterile, LD0608 - C Section - surgical kit conta... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800508, Sterile, LD0586 - C Section - surgical kit conta... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit ... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit containi... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit contai... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800548, Sterile, OR0637 - Extremity - surgical kit contai... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit con... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800526, Sterile, ET0610 - Head and Neck - surgical kit co... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800559, Sterile, ET0648 - Head & Neck - surgical kit cont... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - surgical ... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800557, Sterile, LD0646 - C-Section - surgical kit contai... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk - surgical kit ... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit cont... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk - surgical ki... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit cont... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical ... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit contai... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical kit con... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit contai... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit contain... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containi... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit co... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit con... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical ... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical ... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation Llc
Apr 22, 2015 regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical ... The kits contain an equipment glove component which may contain splits or holes compromising the ... Class II Resource Optimization & Innovation 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.