Brand Name: Sterile Tourniquet Hoses Product Name: A — Class II medical device recall Z-2674-2026
Ongoing recall by Zimmer Surgical Inc, reported 2026-07-08, distributed nationwide. Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized i
| Recall number | Z-2674-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Surgical Inc, Dover, OH, United States |
| Recall initiated | 2026-06-09 |
| Classified | 2026-07-02 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 14,360 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00889024376786, 00889024380455, 00889024382336 |
| Lot numbers | 79701946, 79701947, 79701948, 80555938, 80555939, 80555940, 80581869, 80581870, 80765021 |
| Model numbers | 60-4009-101-00 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2674-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.