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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Apr 24, 2017 Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053... Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor... Class I Respironics California Inc
Feb 1, 2017 Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ven... The V60 Ventilator with Version 2.20 software installed may falsely detect that the blower motor ... Class II Respironics California Inc
Oct 29, 2014 Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V... If the power supply fan mounting screws are installed incorrectly, the ends of the screws may tou... Class II Respironics California Inc
Sep 17, 2014 Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Gene... A failure of a specific component may prevent the ventilators from operating on AC power or trans... Class I Respironics California Inc
Jun 4, 2013 Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 1... Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue wit... Class I Respironics California Inc
Jul 31, 2012 V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usag... Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ve... Class I Respironics California Inc
Oct 29, 2007 Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model... The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark... Class II Respironics California Inc

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.