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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
Jul 19, 2019 MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to... Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause... Class III Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Jul 2, 2019 Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage... Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue ... Class II Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Jul 2, 2019 Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature ... Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue ... Class II Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Jul 2, 2019 CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool ... Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue ... Class II Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Jun 20, 2019 Norm-O-Temp model 111W The manual does not provide instruction stating that exceeding 40 Celsius for extended periods ca... Class II Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Jun 20, 2019 Norm-O-Temp model 111Z The manual does not provide instruction stating that exceeding 40 Celsius for extended periods ca... Class II Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Dec 19, 2018 Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: ... Evidence supports that when customers performed a fuse replacement as part of a March 2017 field ... Class II Cincinnati Sub-Zero Products LLC, a Gentherm Co...
Sep 4, 2018 Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Rese... Potential for membrane (control panel) switch errors leading to an inability of the device to cha... Class II Cincinnati Sub-Zero Products LLC, a Gentherm Co...

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.