Vapotherm Precision Flow — Class II medical device recall Z-2701-2014
Terminated recall by Vapotherm, Inc., reported 2014-10-01, distributed nationwide. Disposable Patient Circuit that allows water to leak into the center gas lumen
| Recall number | Z-2701-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vapotherm, Inc., Exeter, NH, United States |
| Recall initiated | 2014-08-13 |
| Classified | 2014-09-25 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2015-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, DE, ES, FR, GB, HK, IE, IL, IT, KR, KW, MX, SE |
| Quantity | 635 units |
| Reason classes | packaging |
| Lot numbers | 1402021, 1402024 |
Product
Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Reason for recall
Disposable Patient Circuit that allows water to leak into the center gas lumen
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-2701-2014. 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.