Zimmer Surgical Inc: Tourniquet, Pneumatic
Recall Summary Zimmer Surgical Inc is recalling sterile tourniquet hoses (model 60-4009-101-00) used in surgical settings because the sterile packaging may have a breach in the sealing area, potentially allowing contamination. If used, the device could cause a moderate localized infection; if the problem is found before use, surgery may be delayed while staff locate a replacement device. The affected product was distributed nationwide in the US 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 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
- 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/6d3057f9-9034-4bf2-ad93-1b0ad66a4e50