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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Jun 10, 2013 Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL ... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Pr... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 E... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriT... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributo... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., Inc.
Jun 10, 2013 Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributo... Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involvi... Class II Steritec Products Mfc. Co., 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.