with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc… — Class II medical device recall Z-0405-2024
Ongoing recall by Breas Medical, Inc., reported 2023-12-06, distributed nationwide. Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation
| Recall number | Z-0405-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Breas Medical, Inc., North Billerica, MA, United States |
| Recall initiated | 2023-10-13 |
| Classified | 2023-11-27 |
| Reported by FDA | 2023-12-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 215 units |
| UPC / GTIN / UDI-DI | 05030267120505, 07321820060931, 07321820066537 |
| Lot numbers | 32304444, 32305269, 32306017 |
Product
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.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0405-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.