Vapotherm Precision Flow Disposable Patient Circuit Recall for Water Leakage
Vapotherm, Inc. is recalling 360 units of Precision Flow Disposable Patient Circuits because they allow water to leak into the center gas lumen.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional defect (water leakage) in a medical device where no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Vapotherm, Inc. is recalling 360 units of Vapotherm Precision Flow Disposable Patient Circuits (PF-E-DPC-Low and PF-DPC-Low). The recall affects lots 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers apply regardless of the prefix preceding them (HF, HFE, HFH, HFN, LF, LFE, LFH, or LFN).
The recall was initiated because the disposable patient circuits allow water to leak into the center gas lumen. The affected products were distributed nationwide in the United States and internationally to Canada, France, Switzerland, Korea, Sweden, Germany, Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, Kuwait, and Italy.
Healthcare facilities and consumers should stop using the affected patient circuits and contact Vapotherm, Inc. for instructions on return or replacement.
The recalled product
- Product
- Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system
- Manufacturer
- Vapotherm, Inc.
- Affected units
- 360
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot Numbers 1402021 through 1406010
- HFE
- HFH
- HFN
- LF
- LFE
- LFH or LFN).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Vapotherm, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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