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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Jan 3, 2023 Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only)... Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher t... Class II Western/Scott Fetzer Company
Oct 16, 2021 Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840 VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... Class II Western/Scott Fetzer Company
Oct 16, 2021 Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600 VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... Class II Western/Scott Fetzer Company
Oct 16, 2021 Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS... VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... Class II Western/Scott Fetzer Company
Oct 16, 2021 Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS... VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to ... Class II Western/Scott Fetzer Company

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.