Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093 Recalled by Breas Medical, Inc. Due to Produced with unintended open slits on the side...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Breas Medical, Inc. directly.
Affected Products
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.
Quantity: 215 units
Why Was This Recalled?
Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Breas Medical, Inc.
Breas Medical, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report