Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 6, 2023
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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Breas Medical, Inc. recalled with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, … - a moderate-severity action.
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, … was recalled by Breas Medical, Inc. in December 6, 2023. Reason: Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilatio…. Check the official notice for the remedy. Verify recall #Z-0405-2024 with the FDA Devices before acting.
The recall
Breas Medical, Inc. issued this moderate-severity FDA Devices recall-Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilatio….
- Moderate
- severity level
- 215 units
- affected scope
- Class II
- classification
- December 6, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0405-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0405-2024) was formally reported on December 6, 2023, with the manufacturer initiating the action on October 13, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Breas Medical, Inc. is listed as the recalling firm, operating out of North Billerica, MA. Federal records list the affected scope as 215 units.
The documented reason for this recall is: 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 Distribution data in the federal record shows the product reached: Nationwide Foreign: Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
215 units
Related Recalls
6
3 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0405-2024 |
| Date reported | December 6, 2023 |
| Date initiated | October 13, 2023 |
| Recalling firm | Breas Medical, Inc. |
| Firm location | North Billerica, MA |
| Affected scope | 215 units |
| Distribution | Nationwide Foreign: Canada |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0405-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Breas Medical, Inc.. Units affected: 215 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 6, 2023. Severity: Moderate. Recall number: Z-0405-2024.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0405-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 6, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.