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Browse Device Recalls

917 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 917 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 917 FDA device recalls in MO.

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DateProductReasonClassFirm
Apr 20, 2017 VITEK¿ 2 Streptococcus Susceptibility card (AST-ST02), IVD, REF 420915, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-GN70), REF 413401, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N279), REF 414492, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N297), IVD, REF 415672, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N194), REF 412605, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N353), IVD, REF 421297, 20 c... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P605), REF 22325 20 cards per... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N203), REF 412864, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-GN76), REF 413433, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N340), IVD, REF 419412, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N195), REF412609, 20 cards pe... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P586), REF 22276, 20 cards pe... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P600), REF 22313, 20 cards pe... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards pe... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N212), REF 413061, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per car... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards pe... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N359), IVD, REF 421573, 20 c... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P631), REF 414961, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N265), REF 413865, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N362), IVD, REF 421585, 20 c... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N214), REF 413064, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N222), REF 413083, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P607), REF 22335, 20 cards pe... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N300), IVD, REF 416241, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N268), REF 413868, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards p... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P580), REF 22233, 20 cards pe... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Positive Susceptibility card (AST-P648), IVD, REF 420857, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Apr 20, 2017 VITEK¿ 2 Gram Negative Susceptibility card (AST-N351), IVD, REF 421257, 20 ca... The integrity of the product container may be compromised thereby exposing product to moisture wh... Class II Biomerieux Inc
Mar 7, 2017 uNion Cervical Plate System Product Usage: The uNion Cervical Plate Syste... Surgical technique was revised to prevent static plate screws blocking mechanisms from disassocia... Class II Ulrich Medical USA Inc
Feb 27, 2017 Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim... Software issue. The difference between the display and dosimeter readings In the Child/Pediatric... Class II LIEBEL-FLARSHEIM COMPANY LLC
Feb 27, 2017 Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim ur... Software issue. The difference between the display and dosimeter readings In the Child/Pediatric... Class II LIEBEL-FLARSHEIM COMPANY LLC
Jan 30, 2017 A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism... During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. Class II ErgoSafe Products, LLC (DBA) Prism Medical
Jan 30, 2017 A-series lift - A625 Manual Part No. 324117. Prism Medical. During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. Class II ErgoSafe Products, LLC (DBA) Prism Medical
Jan 9, 2017 Regard, Item Number: 800558001, Sterile, OR0647A - 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: 800524002, Sterile, LD0608B - 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: 800546001 Sterile, GS0635A - 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: 800554003, Sterile, GS0643C - Pediatric Basic - Children... 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: 800418003, Sterile, GY0487C - 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: 880321002, Sterile, GS0752B - Breast 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: 800551001, Sterile, GS0640A - 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: 800414001, Sterile, OR0483A - 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: 800036004, Sterile, LD0274D - C Section Pack - FMOL St F... 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: 800533002 Sterile, GS0606B - 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: 880327005, Sterile, CV0758E - 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: 800566002, Sterile, NU0655B - VP Shunt - 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: 880321003, Sterile, GS0752C - Breast 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: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Sa... 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.