Vyaire Flexible Patient Circuits 3100A Distributed Without U.S. Approval
Vyaire's Flexible Patient Circuits (29028-004) for the 3100A ventilator were distributed in the U.S., despite being approved only for use outside the U.S. They do not meet U.S. regulatory requirements.
What this means for you
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: Ventilator patient circuits are inherently high-risk medical devices used in critical care settings. This FDA Class II recall involves devices distributed in the U.S. market where they have not been approved, indicating they do not meet U.S. regulatory requirements for safety and effectiveness. While no injuries have been reported, the regulatory non-compliance involving high-risk devices warrants a High severity rating.
Plain-English summary
Vyaire Medical is recalling two models of Flexible Patient Circuits (models 29028-003 and 29028-004) intended for use with the 3100A High Frequency Oscillatory Ventilator. These circuits are approved by the FDA only for use outside the United States. They were inappropriately distributed in the United States, where they have not been approved for use and therefore do not meet U.S. regulatory requirements for safety and effectiveness.
The model 29028-004 circuits were distributed in Florida. Affected facilities received 16 circuits across 10 specific lot numbers: 4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792.
Healthcare providers who have these circuits should contact Vyaire Medical or the FDA for guidance on return, replacement, or appropriate disposal.
The recalled product
- Product
- vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
- Manufacturer
- Vyaire Medical
- Hazard
- regulatory-non-compliance
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 (10)
- UDI/DI 10190752155251: Lot/serial numbers: 4022993
- 4160569
- 4160570
- 4163199
- 4163200
- 4165472
- 4166359
- 4231715
- 4243198
- 4253792
Distribution
Distribution scope not specified by the agency.
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