Browse Device Recalls

228 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 228 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 228 FDA device recalls.

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DateProductReasonClassFirm
Aug 19, 2015 Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG ... Surgical kits contain a surgical scrub product which may be chemically contaminated and lack ster... Class II Resource Optimization & Innovation Llc
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
Apr 22, 2015 regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - 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: 800569001, Sterile, CV0659A - Open Heart A&B - 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 800568001, Sterile, OR0658A - Titanium Rib - 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: 800091001, Sterile, LD0692A - C Section - 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: 800551, Sterile, GS0640 - Lap Chole - 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: 800514, Sterile, LD0592 - C Section 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: 800623, Sterile, NU0787 - 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

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.