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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Apr 2, 2019 Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bat... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath ... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model N... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath ... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath ... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath ... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Apr 2, 2019 Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model ... Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction... Class II Thermo Fisher Scientific (Asheville) LLC
Nov 29, 2012 CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381,... Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in... Class II Thermo Fisher Scientific (Asheville) LLC

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.