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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
Apr 18, 2017 ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator... ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR... Class II ELITech Clinical Systems SAS
Sep 22, 2015 Eon 300 system includes the following product reference numbers and names: ... ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system... Class II ELITech Clinical Systems SAS
Sep 22, 2015 Envoy 500 system includes the following product reference numbers and names: ... ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument syst... Class II ELITech Clinical Systems SAS
Sep 22, 2015 Eon 100 system included the following product reference numbers and names: ... ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system... Class II ELITech Clinical Systems SAS
Sep 22, 2015 ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems ... ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM sy... Class II ELITech Clinical Systems SAS
Aug 11, 2014 ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. ... Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing tha... Class III ELITech Clinical Systems SAS

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.