Recall Z-1201-2026 ยท KCY Tourniquet, Pneumatic
Zimmer Surgical Inc
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S. 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S. 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A
| Date | Jan 28, 2026 (initiated Dec 24, 2025) |
| Status | Open, Classified |
| Reason | Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located. |
| Root cause | Under Investigation by firm |
| Action | On December 30, 2025, the firm began notifying consignees through Urgent Medical Device Recall letters. The firm is conducting this recall in two phases. In Phase 1, which began on 12/30/2025, consignees are informed that the screen may freeze or stop responding to touch when used in certain international languages. Users may continue to use the device by utilizing the English language mode. Use of the device in an affected language is not advised, and may cause the issue to occur. ATS5000 Affected Languages: Czech, Danish, Finnish, French, Italian, Lithuanian, Norwegian, Romanian, Slovak, |
| Quantity | 206 |
| Distribution | International distribution to the countries of Canada and EMEA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202919 | ATS 5000 Automatic Tourniquet Instrument Mcewen and Associates Consulting , Ltd., May 20, 2021 |