Class II — Vapotherm
| Recalling firm | VAPOTHERM, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout. |
| Product | Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW |
| Quantity | 5869 total |
| Distribution | Worldwide distribution - US Nationwide and the country of UK. |
| Initiated | 2022-12-16 |
| Classified | 2023-03-17 |
| Recall number | Z-1272-2023 |
| 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 II recall — Vapotherm (Z-1272-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91579/
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