Recall Z-1201-2026
Zimmer Surgical Inc · initiated December 24, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Lot Code: Model No. 60500010100 ; UDI (01)00889024626454(11)240410(10)66722609(21)50066722609001; Lot No. 66722609 ; Serial No. 50066722609001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609002; Lot No. 66722609 ; Serial No. 50066722609002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609003" ; Lot No. 66722609 ; Serial No. 50066722609003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609004" ; Lot No. 66722609 ; Serial No. 50066722609004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609005" ; Lot No. 66722609 ; Serial No. 50066722609005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610001" ; Lot No. 66722610 ; Serial No. 50066722610001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610002" ; Lot No. 66722610 ; Serial No. 50066722610002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610003" ; Lot No. 66722610 ; Serial No. 50066722610003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610004" ; Lot No.…
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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, Slovenian, and Turkish Unaffected Languages: English, Chinese (simplified), Korean, Japanese, Greek, Bulgarian, and Russian All devices manufactured between April 2024 - September 2025 with software version v2.04 are within scope of the recall. Affected devices will require an upgrade to the new software version v2.05 when it is available in early 2026. The firm will issue a removal notice (Phase 2) once the new software version is available. Customers are instructed to not return affected devices before the initiation of Phase 2.
Details
- Recall number
- Z-1201-2026
- Initiated
- December 24, 2025
- Posted by FDA
- January 28, 2026
- Product code
- KCY – Tourniquet, Pneumatic
- Quantity
- 206
- Distribution
- International distribution to the countries of Canada and EMEA only.
- Recalling firm
- Zimmer Surgical Inc, Dover, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1202-2026 Class II | Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S. 3200TS Tourniquet Systems…Device user interface (screen) may freeze or become unresponsive to touch when operating in certain… | 12/24/2025Open, Classified |