Exeter, NH, United States
Vapotherm recalls
1 recall recorded since 2018, most recently on 16 December 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 December 2022
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the country of UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1272-2023
- Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.