Vapotherm Precision Flow — Class II medical device recall Z-2706-2014
Terminated recall by Vapotherm, Inc., reported 2014-10-01, distributed nationwide. Water may leak into the center gas lumen of the Patient Circuit
| Recall number | Z-2706-2014 |
|---|---|
| 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 | 207 units |
| Reason classes | packaging |
| Lot numbers | 1402021, 1402024 |
Product
Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system
Reason for recall
Water may leak into the center gas lumen of the Patient Circuit
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-2706-2014. 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.