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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
Sep 18, 2025 Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Ki... When unintentionally disconnected from power source, humidifier device (used to deliver high flow... Class II Fisher & Paykel Healthcare, Ltd.
Aug 7, 2024 PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/o... Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the... Class II Fisher & Paykel Healthcare, Ltd.
Apr 2, 2024 Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured befor... Class II Fisher & Paykel Healthcare, Ltd.
Nov 6, 2014 Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and P... Breakage of the nut that secures the heater head in place, which can cause the heater head to bec... Class II Fisher & Paykel Healthcare, Ltd.
Apr 15, 2014 Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP... The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is like... Class I Fisher & Paykel Healthcare, Ltd.
Apr 22, 2013 Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). ... Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power ... Class II Fisher & Paykel Healthcare, Ltd.
Nov 19, 2012 Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing ... FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes... Class I Fisher & Paykel Healthcare, Ltd.

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.