FDA Device recall Z-1201-2026
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: S…
- FDA Device
- Class II
- ongoing
- Published 2026-02-04
On 2026-02-04 the FDA classified a Class II recall of Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: S… by Zimmer Surgical, citing 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 alterna….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1201-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-24 |
| Published | 2026-02-04 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Zimmer Surgical |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Lot Code: Model No. 60500010100 ; UDI (01)00889024626454(11)240410(10)66722609(21)50066722609001; Lot No. 66722609 ; Se…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)0088902462 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1201-2026%22
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