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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Jun 10, 2014 Animas Vibe Insulin Infusion Pump. This product is indicated for continuou... Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was inco... Class II Animas Corporation
Jan 3, 2013 Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indic... Animas has identified a component issue affecting a small supply of the Animas(R) 2020 insulin pu... Class I Animas Corporation
Dec 17, 2012 Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infu... Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on J... Class III Animas Corporation
Oct 25, 2012 Animas Vibe Insulin Infusion Pump and System. These products are indicated... Animas determined that keypad wear over time was contributing to an increased complaint rate asso... Class II Animas Corporation
Jul 16, 2012 IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump gluco... Wear of the keypad that may lead to damage such as tearing or peeling of the edge of the keypad f... Class II Animas Corporation
Sep 6, 2011 Animas Vibe Insulin Infusion Pump. This product is indicated for continuou... Calibration factors in the pump overwritten during a programming step. The force sensor could sen... Class II Animas Corporation

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.