RecallRadar

FDA Device recall Z-3207-2024

Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only

On 2024-10-09 the FDA classified a Class I recall of Percussionaire, Inc., REF: P5-TEE, Qty: 1, 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-3207-2024
ClassificationClass I
Statusongoing
Initiated2024-08-21
Published2024-10-09
Last updated2026-09-13 11:57 UTC
CompanyPercussionaire
DistributionUS

Product

Percussionaire, Inc., REF: P5-TEE, Qty: 1, 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, WO…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-3207-2024%22

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