FDA-Device2026-07-08Class IIPACKAGING DEFECT
Zimmer Surgical A.T.S. 4000 TS Tourniquet Hoses recalled for sterility breach risk
What this means
Certain sterile tourniquet extension hoses may have a breach in the sealing area of the sterile pouch, which could allow contamination. If used without detection, the hose could potentially cause a moderate localized infection at the surgical site.
- Check inventory for affected lot numbers (79701946, 79701947, 79701948, 80555938, 80555939, 80555940, 80581869, 80581870, 80765021).
- Do not use affected hoses in surgical procedures.
- Contact Zimmer Surgical or your hospital supply chain for replacement devices and return instructions.
The agency's original wording
Hazard
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada and EMEA.
Affected count
14360
Manufactured in
200 W Ohio Ave, N/A, Dover, OH, United States
Products
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2674-2026More Zimmer Biomet recalls
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