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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: 800411003, Sterile, NU0480C- 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: 800553003, Sterile, OR0642C - 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: 800553001, Sterile, OR0642A - 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: 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: 800415002, Sterile, OR0484B- Shoulder System 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: 800558004, Sterile, OR0647D - 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: 800036005, Sterile, LD0274E - C Section Pack - FMOL St ... 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: 800422003, Sterile, OR0491C - 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: 880323001, Sterile, LD0754A - C Section - 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: 800533001, Sterile, GS0606A - Abdominal Pk - 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: 800410003, Sterile, CV0479C - 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: 800524003, Sterile, LD0608C - C Section - 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: 800419002, Sterile, GY0488B - D&C 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: 800326002, Sterile, GS0757B - Major Basin - 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: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa 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: 800414002, Sterile, OR0483B- Total Joint 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: 800414003, Sterile, OR0483C - Total Joint 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: 800557001, Sterile, LD0646A - 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: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa 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: 800417002, Sterile, GY0486B - 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: 800091002, Sterile, LD0692B - 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: 800528002 Sterile, GS0612B - Lap Chole PK - 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: 880328001, Sterile, HT0759A - Pacemaker Pk - 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: 800535001, Sterile, LD0620A - 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: 800415001, Sterile, OR0484A - Shoulder System 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: 800430005, Sterile, LD0499E - 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: 800413005, Sterile, CV0482E- 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: 800528005 Sterile, GS0612E - Lap Chole PK - 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: 800560003, Sterile, GS0649C - Lap Chole - Childrens San... 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: 880328002, Sterile, HT0759B - Pacemaker Pk - 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: 800560002, Sterile, GS0649B - Lap Chole - 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: 800558003, Sterile, OR0647C - 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: 800550001, Sterile, OR0639A - 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: 880326001, Sterile, GS0757A - Major Basin - 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: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo 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: 800410004, Sterile, CV0479D- 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: 800551002, Sterile, GS0640B - 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: 800415003, Sterile, OR0484C- Shoulder System 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: 800526003 Sterile, ET0610C - 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
Aug 25, 2015 Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical ki... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical ki... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom pro... The kits contain pressure monitoring kits or sets which are being recalled as a result of flow re... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical k... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical ki... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for car... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular s... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 25, 2015 Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical ki... Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... Class II Resource Optimization & Innovation Llc
Aug 19, 2015 Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. U... Surgical kits contain a surgical scrub product which may be chemically contaminated and lack ster... 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.