Recall Z-2674-2026 ยท KCY Tourniquet, Pneumatic
Zimmer Surgical Inc
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
| Date | Jul 2, 2026 (initiated Jun 9, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On June 8, 2026, the firm began notifying consignees titled "URGENT MEDICAL DEVICE RECALL." Customers were instructed to locate and quarantine affected product in their inventory. Customers may either return the affected product, or a Zimmer Biomet sales representative may remove and return the affected product on the customer's behalf. If the product has been further distributed, the distributor should notify downstream customers and accounts of the recall. All customers should ensure that affected personnel are aware of the recall. This recall is related to prior recall RES 98665, conduct |
| Quantity | 14360 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada and EMEA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.