FDA recall, , Moderate risk
Zimmer Biomet A.T.S. 4000 TS Tourniquet System Sterile Hoses
Sterile tourniquet hoses may have a sterility breach, potentially causing moderate localized infection.
Summary by Recall Canary from the FDA notice
What happened
Zimmer Surgical Inc of Dover, Ohio, recalled A.T.S 4000 TS Tourniquet Systems Single Hose with CPC Connectors and A.T.S 4000 TS Tourniquet Systems Dual Hose with CPC Connectors due to a potential sterility breach in the sealing area of the sterile pouch.
If used, the issue may result in moderate localized infection, and if discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device. The recall began June 9, 2026, and was added to the FDA's Enforcement Report on July 2, 2026. The products were distributed nationwide and in Canada and EMEA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors
- UDI-DI
- 00889024382336
- 79701946
- 00889024380455
- 00889024376786
- 79701947
- 79701948
- 80555938
- 80555939
- 80555940
- 80581869
- 80581870
- 80765021
- Model/Catalog number
- 60-4009-101-00
Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors
- UDI-DI
- 00889024381162
- 78938271
- 00889024378469
- 00889024367173
- 78938272
- 78938273
- 80555986
- 80555987
- 80555988
- 80555989
- 80555990
- 80568849
- 82010858
- 82010859
- 82196691
- 82196692
- 82331021
- 82331022
- 82418900
- 82418901
- 82639501
- 82761025
- 83343102
- 84859541
- 84859542
- 86156905
- Model/Catalog number
- 60-1812-101-00
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada and EMEA.
- Company
- Zimmer Surgical IncDover, Ohio
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99186
- Recall numbers
- Z-2673-2026 to Z-2674-2026
All recalls from Zimmer Surgical Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
