Official recall record
A.T.S® 4000 TS Tourniquet Systems Single and Dual Hose with CPC Connectors
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-06-23
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Zimmer Biomet is conducting a medical device recall for A.T.S® 4000 TS Tourniquet Systems Single and Dual Hose with CPC Connectors. One (1) complaint was received with no clinical impact reporting that wrinkles were identified in the sealing area of the sterile pouch. Subsequent seal integrity testing conducted internally showed potential sterility breach in 0.92% of inspected units that had visual seal nonconformities. The devices are distributed in cases (CS) of 20 units. Inside each case are two boxes (BX) of 10 units each.
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.
Record last checked against the registry on 2026-07-03.