Zimmer Surgical Inc: Tourniquet, Pneumatic
Zimmer Surgical is recalling A.T.S 4000 TS Tourniquet System Dual Hoses (model 60-1812-101-00) due to a potential breach in the sterile pouch's sealing area that could allow contamination. If used, the affected hoses could cause a moderate localized infection during surgery. The recall affects products distributed nationwide in the U.S. and in Canada and Europe.
- Recalling firm
- Zimmer Surgical Inc
- Product
- Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-09
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada and EMEA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/3b4ff503-e059-4f2a-96fd-964e9562201e