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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
Jan 9, 2017 Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover H... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical C... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Sant... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Cen... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800411002, Sterile, NU0480B- Neuro PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Cente... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800408004, Sterile, LD0477D - C-Section PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800416001, Sterile, GY0485A - Robotic Hysterectomy Pk - ... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800401001, Sterile, GS0470A - Lap PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800546002, Sterile, GS0635B - Abdominal - Medical Center... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800551003, Sterile, GS0640C - Lap Chole - Medical Center... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800559002, Sterile, ET0648B - Head & Neck - Childrens Sa... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Chil... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover ... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover ... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800413003, Sterile, CV0482C - Vascular PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of ... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800557002, Sterile, LD0646B - C Section - Childrens Sant... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800430004, Sterile, LD0499D - C Section Pk - Cabrini Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800559003, Sterile, ET0648C - Head & Neck - Childrens Sa... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800401002, Sterile, GS0470B - Lap PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover H... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800599003, Sterile, GS0694C - Robotic Lap - Christus Hig... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880330004, Sterile, OR0761D - Total Hip - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Hig... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center San... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... 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.