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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Aug 8, 2017 Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. ... Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecti... Class I Leonhard Lang Medizintechnik GmbH
Sep 1, 2016 Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifuncti... There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillat... Class I Leonhard Lang Medizintechnik GmbH
Nov 2, 2015 ECG Electrodes: 50007  Stablebase SBW55 50675  Stablebase SBW55-15 580... There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that th... Class II Leonhard Lang Medizintechnik GmbH
Feb 24, 2015 Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electro... The electrodes may fail to transmit signals. Class II Leonhard Lang Medizintechnik GmbH

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.