Vyaire Flexible Patient Circuit 3100A Distributed Without U.S. Approval
Vyaire Medical recalled 188 Flexible Patient Circuit 3100A units distributed in Florida that were approved only for use outside the United States. The circuits were mistakenly distributed in the U.S. market.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory non-compliance—circuits approved only for use outside the United States were distributed in the U.S. market. This is primarily a distribution compliance issue rather than a direct product defect.
Plain-English summary
Vyaire Medical is recalling 188 Flexible Patient Circuit 3100A units (REF 29028-003) intended for use with the 3100A High Frequency Oscillatory Ventilator (HFOV). The recall affects circuits with the following lot numbers: 4060467, 4165459, 4167324, 4180598, 4180599, 4180604, 4180609, 4180610, 4180611, 4182155, 4182156, 4182157, 4182158, 4182159, 4182160, 4182161, 4182162, 4182163, 4182164, 4183410, 4183411, 4188658, 4190144, 4253788, 4253789, and 4180603 (UDI/DI 10190752159747).
These patient circuits were approved for use only outside the United States but were distributed in the U.S. market, specifically in Florida.
Healthcare facilities in Florida that received these units should verify whether they have these circuits in inventory and take appropriate corrective action in accordance with FDA guidance and their facility protocols.
Vyaire Medical and the FDA are working to address this distribution error. Affected facilities should contact the manufacturer for instructions on proper handling of recalled units.
The recalled product
- Product
- vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
- Manufacturer
- Vyaire Medical
- Affected units
- 188
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 (20)
- UDI/DI 10190752159747: Lot/serial numbers: 4060467
- 4165459
- 4167324
- 4180598
- 4180599
- 4180604
- 4180609
- 4180610
- 4180611
- 4182155
- 4182156
- 4182157
- 4182158
- 4182159
- 4182160
- 4182161
- 4182162
- 4182163
- 4182164
- 4183410
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Vyaire Medical 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 2 products in this recall →Related recalls
Same manufacturer · Vyaire Medical
See all →- SevereAirLife Infant Heated Wire Circuit Adapter Disconnection Risk
FDA (Devices) · 2025-05-21
- SevereAirLife Infant Heated Wire Circuit Adapter Disconnection Risk Recall
FDA (Devices) · 2025-05-21
- SevereAirLife Manual Resuscitator recalled for broken components causing ventilation failure
FDA (Devices) · 2024-03-06
- SevereAirLife Adult Manual Resuscitator units recalled for component failure
FDA (Devices) · 2024-03-06
- SevereAirLife Adult Manual Resuscitator recalled for ventilation failure risk
FDA (Devices) · 2024-03-06
Same hazard · regulatory non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
Similar recalls
- SevereVyaire Medical Ventilators Recalled Due to Potential Ventilation Failure
FDA (Devices) · 2022-02-23
- SevereServo-u ventilators may measure patient circuit compliance inaccurately
FDA (Devices) · 2025-07-09
- SevereVyaire Medical Recalls AirLife Adult Resuscitation Devices Due to Airflow Obstruction
FDA (Devices) · 2018-08-15
- SevereVyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Airflow Obstruction Risk
FDA (Devices) · 2018-08-15
- HighVyaire Medical Recalls bellavista 1000 Ventilators Due to Alarm Failures
FDA (Devices) · 2020-03-11
- CriticalVyaire Medical Recalls enFlow Cartridges Due to Aluminum Elution
FDA (Devices) · 2019-07-03