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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Sep 17, 2025 Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: ... IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't us... Class I Percussionaire Corporation
Dec 23, 2024 VDR4 Phasitron Breathing Circuit Models that contain the venturi component: ... Due to internal venturi component getting transiently stuck in the forward position within the br... Class I Percussionaire Corporation
Sep 16, 2024 Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulm... As a result of product complaints, breathing circuits are experiencing discolored fluid which are... Class I Percussionaire Corporation
Aug 21, 2024 Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Perc... Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intra... Class I Percussionaire Corporation
Aug 21, 2024 Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary ... Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intra... Class I Percussionaire Corporation
Dec 12, 2023 High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx On... Due to an assembly error within the breathing circuit, their pressure output of the breathing cir... Class I Percussionaire Corporation
Mar 28, 2023 Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control dri... Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result... Class I Percussionaire Corporation
Sep 14, 2020 Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators. Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of wavefo... Class II Percussionaire Corporation

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.