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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Oct 2, 2023 STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vit... Deterioration in the stability of the Test Strips results in diminished low-range detection capab... Class II Stanbio Laboratory, LP
Mar 16, 2022 Separation Technology Creamatocrit Plus, Catalog Number: 100-146 The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics ... Class II Stanbio Laboratory, LP
Jul 12, 2021 Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vi... Deterioration in the stability of the reagents which has resulted in lower than expected or out o... Class III Stanbio Laboratory, LP
Jul 12, 2021 Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. Deterioration in the stability of the reagents which has resulted in lower than expected or out o... Class III Stanbio Laboratory, LP
Jul 12, 2021 Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. Deterioration in the stability of the reagents which has resulted in lower than expected or out o... Class III Stanbio Laboratory, LP
Jul 12, 2021 Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent. Deterioration in the stability of the reagents which has resulted in lower than expected or out o... Class III Stanbio Laboratory, LP
Jul 12, 2021 Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic rea... Deterioration in the stability of the reagents which has resulted in lower than expected or out o... Class III Stanbio Laboratory, LP
Feb 13, 2018 RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (... All patient serum samples yield a weakly positive test result. Class II Stanbio Laboratory, LP
Feb 8, 2018 Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The... The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outl... Class II Stanbio Laboratory, LP

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.