Class I — Percussionaire Corporation
| Recalling firm | PERCUSSIONAIRE CORP. |
|---|---|
| Registered facility | PERCUSSIONAIRE CORP. (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy. |
| Product | Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve |
| Quantity | 2523 units |
| Distribution | US: Nationwide OUS: Israel Japan Russia Switzerland Canada Turkey |
| Initiated | 2024-08-21 |
| Classified | 2024-09-27 |
| Recall number | Z-3208-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Percussionaire Corporation (Z-3208-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95239/
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