ProductGuru Recalls

Official recall record

NIV Angled Mouthpiece with Notch 22F/15F

Health Canada — Medical Devices · 2023-11-09 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2023-11-09
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

The manufacturer of the NIV angled mouthpiece with Notch 22F/15F, advised that devices in lots 32304444, 32305269 and 32306017 were produced with unintended open slits on the side of the mouthpiece body. This allows some of the respiratory gas to escape and thus reduces effectiveness of the related Vivo 45 LS US device. Breas Medical traced these lots and determined that shipments from April 4th, 2023 until July 31st, 2023 could be affected by the issue. Recall Start Date: October 13, 2023

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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