Disposable Patient Circuit with Precision Flow System recalled for excessive condensation
Vapotherm has recalled 5,869 Low Flow Disposable Patient Circuits for the Precision Flow System due to reports of excessive condensation that may lead to rainout.
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: This is a Class II medical device recall involving a respiratory patient circuit with reported potential for excessive condensation and rainout. No illnesses, injuries, or deaths are reported in the source. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Vapotherm is recalling 5,869 Low Flow Disposable Patient Circuits (Product Code PF-DPC-LOW) for use with the Precision Flow System. The circuits are affected by reports of excessive condensation in certain lots, which may lead to excessive rainout—moisture accumulation within the breathing circuit.
The recall affects multiple lot numbers distributed worldwide, including throughout the United States and the United Kingdom. The affected lot numbers include LFVMA8503, LFVMA8504, LFVMA8567, LFVLE8568, LFTL41015, LFVLC8399, LFVLE8495, LFVMA8502, LFTL41261, LNTL41544, LFVLE8588, LFVMA8507, LFVLE8494, LFTL41263, and LFTL41262.
Healthcare facilities and patients using the Precision Flow System with these patient circuits should refer to the FDA notice for further guidance on the recall.
The recalled product
- Product
- Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
- Manufacturer
- Vapotherm
- Affected units
- 5,869
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 (5)
- UDI-DI: 00841737104971
- Lot Numbers: LFVMA8503
- LFVMA8504
- LFVMA8567
- UDI-DI: 00841737104978
Distribution
Distributed nationwide across the United States.
Related recalls
Other medical device recalls
- ModerateDRG Sperm Ab ELISA Recalled for Potential False Negative Results
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
Similar recalls
- HighVapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage
FDA (Devices) · 2014-10-01
- HighVapotherm Precision Flow Patient Circuits Recalled for Water Leakage
FDA (Devices) · 2014-10-01
- HighVapotherm Precision Flow Disposable Patient Circuit Recall for Water Leakage
FDA (Devices) · 2014-10-01
- SevereVapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leaks
FDA (Devices) · 2014-10-01
- HighVapotherm Precision Flow Patient Circuit Recalled for Potential Water Leakage
FDA (Devices) · 2014-10-01
- HighMedtronic Custom Perfusion Systems Recalled Due to Valve Flow Defect
FDA (Devices) · 2018-02-14