Class I — Percussionaire Corporation
| Recalling firm | PERCUSSIONAIRE CORP. |
|---|---|
| Registered facility | PERCUSSIONAIRE CORP. (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user |
| Product | High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123 |
| Quantity | 2145 units |
| Distribution | US:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: None |
| Initiated | 2023-12-12 |
| Classified | 2024-01-17 |
| Recall number | Z-0637-2024 |
| 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-0637-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93476/
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