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Browse Device Recalls

18 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 18 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 18 FDA device recalls.

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DateProductReasonClassFirm
Sep 17, 2020 A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usag... Device malfunction causing the applier to jam, and clip loading failures. Class II Genicon, Inc.
Aug 25, 2020 Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigat... The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery ... Class II Genicon, Inc.
Aug 21, 2018 Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, ... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Aug 21, 2018 Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, thr... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Aug 21, 2018 Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - ... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Aug 21, 2018 Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - ... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Aug 21, 2018 Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - ... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Aug 21, 2018 Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, th... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Aug 21, 2018 Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, th... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Aug 21, 2018 Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, thr... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Aug 21, 2018 Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Aug 21, 2018 Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Pr... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Aug 21, 2018 Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, ... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Aug 21, 2018 Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) ... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Aug 21, 2018 Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, th... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Aug 21, 2018 Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, th... There is potential for the plastic optical tip to become detached from the metal shaft. Class II Genicon, Inc.
Jun 27, 2018 Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device i... Genicon is providing updated IFU labeling to users to provide clarity on how to use the device fo... Class II Genicon, Inc.
Jul 19, 2017 GENICON EZEE Retrieval, sterile, Rx only. Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use. Class II Genicon, 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.