RecallRadar

FDA Device recall Z-3208-2024

Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only

On 2024-10-09 the FDA classified a Class I recall of Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only by Percussionaire, citing updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-3208-2024
ClassificationClass I
Statusongoing
Initiated2024-08-21
Published2024-10-09
Last updated2026-09-13 11:57 UTC
CompanyPercussionaire
DistributionUS

Product

Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve

Reason

Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

Identifiers

code_info
No UDI/Lots: 240620 240610 240418 240326 230612 WO07066 WO07010 WO06020 WO05019 WO04884 WO04827 WO04756 WO04714 WO04656…No UDI/Lots: 240620 240610 240418 240326 230612 WO07066 WO07010 WO06020 WO05019 WO04884 WO04827 WO04756 WO04714 WO04656 WO04625 WO04596 WO04553 WO04398 WO04356 WO04061 WO03846 WO03748 WO03688

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3208-2024%22

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