Official recall record
COBE 2991 Disposable Sets
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-11-13
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Three (3) separate failure modes have been identified that may lead to procedural interruptions, leaks, and subsequent loss of product during use of select COBE 2991 disposable sets. These failure modes include: 1) an improperly bonded spike receptor on the processing bag, 2) a twisted stem tube due to a seized ceramic bearing, and 3) a small hole (a.k.a. pinhole) on the stem tube below the rotating seal. Recall start date: October 21, 2024
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.
Record last checked against the registry on 2026-05-31.
ProductGuru Recalls republishes official safety information with attribution. We are not
the issuing authority and this page is not advice. If this product is a medical device or
medication, speak to a doctor or pharmacist. Found an error?
Report it — corrections are published.