Phasitron 5 — Class I medical device recall Z-0031-2026
Ongoing recall by Percussionaire Corporation, reported 2025-10-22, distributed nationwide. IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates
| Recall number | Z-0031-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Percussionaire Corporation, Sandpoint, ID, United States |
| Recall initiated | 2025-09-17 |
| Classified | 2025-10-14 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CH, CL, GB, IL, JP, QA, RU, TR, ZA |
| Quantity | 59,160 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00849436000723 |
| Lot numbers | 230612, 240326, 240418, 240610, 240620, 240826, 241118, 241121, 241203, 250111, 250116, 250324, 250616, WO04756, WO04827, WO04884, WO05019, WO06020 |
| Model numbers | P5-TEE-20 |
Product
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0031-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.