Browse Device Recalls

929 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 929 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 929 FDA device recalls in MO.

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DateProductReasonClassFirm
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
Jan 1, 2017 Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, ... The microscope may tip over if attachments are fully extended in one line and there is an attempt... Class II Seiler Instr. & Mfg. Co. Inc.
Dec 28, 2016 Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered ... Powdered Surgical Gloves are an FDA banned substance. Class II American Contract Systems, Inc.
Sep 2, 2016 2000 Vascular with 30 Degree option Potential for bed to drop suddenly at the head while a patient is laying on it. Class II Heritage Medical Products, Inc.
Aug 30, 2016 Carry bar which is an accessory to a lift used for patients in hospitals and ... The black plastic puck on the carry bar is breaking resulting in potential for patient harm. Class II ErgoSafe Products, LLC (DBA) Prism Medical
Aug 11, 2016 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part... Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec... Class II Synergetics Inc
Aug 11, 2016 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged ... Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec... Class II Synergetics Inc
Aug 11, 2016 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Prod... Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec... Class II Synergetics Inc
Aug 11, 2016 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 700... Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec... Class II Synergetics Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Feb 24, 2016 VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Ca... Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. a... Class II Biomerieux Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux Inc
Feb 24, 2016 Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 car... Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... Class I Biomerieux 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.