Official recall record
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-09-17
- Country of alert
- United States
- Alert level
- Class I
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00849436000723
- Brand on record
- Percussionaire Corporation
What the authority reported
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2026-08-18 · US FDA — Medical Devices
In-Line Valve, Product Number: P5-TEE
Other recalls from this brand
- 2026-08-18 · US FDA — Medical Devices
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual - 2026-08-18 · US FDA — Medical Devices
Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used - 2026-08-18 · US FDA — Medical Devices
Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used
All 9 official recall notices naming Percussionaire Corporation on this site →