Zimmer Biomet Recalls A.T.S 4000 TS Tourniquet Systems Over Sterility Risk

Zimmer Biomet, operating through Zimmer Surgical, Inc. also trading as Relign Corporation, has issued a medical device recall in Canada for the A.T.S 4000 TS Tourniquet Systems Single and Dual Hose with CPC Connectors. The recall, classified as Type II by Health Canada, affects multiple lot numbers and was initiated due to a potential sterility breach in the sealed pouches of these surgical devices.

What Products Are Being Recalled?

The affected products include two variants of the A.T.S 4000 TS Tourniquet Systems:

• A.T.S 4000 TS Tourniquet Systems Single Hose With CPC Connectors (Model/Catalogue No. 60-4009-101-00) — Affected lot numbers: 79701948, 80555938, 79701947, 80581870, 80765021, 79701946, 80555940, 80555939, 80581869
• A.T.S 4000 TS Tourniquet Systems Dual Hose With CPC Connectors, 20-Pack (Model/Catalogue No. 60-1812-101-00) — More than 10 lot numbers are affected; consumers are advised to contact the manufacturer directly for the complete list.

The devices are distributed in cases of 20 units, with each case containing two boxes of 10 units each.

Why Was This Recall Issued?

The recall was triggered after one complaint was received reporting that wrinkles were identified in the sealing area of the sterile pouch. Although no clinical impact was reported from this initial complaint, Zimmer Biomet conducted internal seal integrity testing, which revealed a potential sterility breach in 0.92% of inspected units that exhibited visual seal nonconformities. A compromised sterile barrier in a surgical device can expose patients to contaminated equipment during procedures, posing a serious infection risk.

Who Is Affected?

This recall is directed at the healthcare audience — specifically hospitals, surgical centers, and medical professionals in Canada who may have received, stored, or used the affected tourniquet systems. The A.T.S 4000 TS Tourniquet Systems are used in general and plastic surgery settings, meaning any facility performing surgical procedures using pneumatic tourniquets from the listed lot numbers could be affected.

What Should You Do?

• Check your inventory immediately for any units matching the recalled lot numbers or catalogue numbers listed above.
• Quarantine and stop using any affected units that are identified in your facility.
• Contact Zimmer Surgical, Inc. (also trading as Relign Corporation) directly for additional information, guidance on returning affected products, and to obtain the full list of affected lot numbers for the Dual Hose variant.
• The manufacturer is located at: 200 W Ohio Avenue, Dover, Ohio, United States, 44622.
• Report any adverse events or patient safety concerns related to this device to Health Canada through the official reporting mechanism at Canada.ca.

Official Statement

According to the Health Canada recall notice (Identification Number: RA-82244), this is a Type II health product recall published on June 23, 2026, with an original recall date of June 15, 2026. Health Canada categorizes this under ‘Health Products – Medical Devices – General and Plastic Surgery.’ The recall was issued in the interest of patient safety, and healthcare facilities are urged to take immediate action upon reviewing their stock of the affected tourniquet systems. No clinical adverse outcomes have been reported at the time of publication, but the risk of sterility compromise warrants precautionary removal of affected units from use.