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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Feb 12, 2019 e500 Automatic Transport Ventilator, Model Number 01EVE500 There is a potential for the unit to catch fire due to one of the screen retaining screws being i... Class I O-Two Medical Technologies, Inc.
Feb 12, 2019 e600 Automatic Transport Ventilator, Model Number 01EVE600 There is a potential for the unit to catch fire due to one of the screen retaining screws being i... Class I O-Two Medical Technologies, Inc.
Feb 12, 2019 e700 Automatic Transport Ventilator, Model Number 01EVE700 There is a potential for the unit to catch fire due to one of the screen retaining screws being i... Class I O-Two Medical Technologies, Inc.
May 14, 2018 O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model... Higher levels of nitrous oxide delivered than specification Class II O-Two Medical Technologies, Inc.
Sep 30, 2015 Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s... For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies ... Class II O-Two Medical Technologies, Inc.
Jun 23, 2015 O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01... Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning devic... Class II O-Two Medical Technologies, 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.