{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "217976", "product_res_number": "Z-1201-2026", "event_date_initiated": "2025-12-24", "event_date_posted": "2026-01-28", "recall_status": "Open, Classified", "res_event_number": "98235", "product_code": "KCY", "k_numbers": [ "K202919" ], "product_description": "Brand Name: Zimmer Tourniquet Systems\nProduct Name: A.T.S. 5000TS Tourniquet Systems\nModel/Catalog Number: 60500010100\nSoftware Version: Software version v2.04 or prior are within scope of the recall for A.T.S. 5000TS\nProduct Description: A.T.S 5000TS Tourniquet Systems\nComponent: N/A", "code_info": "Lot Code: Model No. 60500010100 ; UDI (01)00889024626454(11)240410(10)66722609(21)50066722609001; Lot No. 66722609 ; Serial No. 50066722609001\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722609(21)50066722609002; Lot No. 66722609 ; Serial No. 50066722609002\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722609(21)50066722609003\" ; Lot No. 66722609 ; Serial No. 50066722609003\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722609(21)50066722609004\" ; Lot No. 66722609 ; Serial No. 50066722609004\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722609(21)50066722609005\" ; Lot No. 66722609 ; Serial No. 50066722609005\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722610(21)50066722610001\" ; Lot No. 66722610 ; Serial No. 50066722610001\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722610(21)50066722610002\" ; Lot No. 66722610 ; Serial No. 50066722610002\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722610(21)50066722610003\" ; Lot No. 66722610 ; Serial No. 50066722610003\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722610(21)50066722610004\" ; Lot No. 66722610 ; Serial No. 50066722610004\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722610(21)50066722610005\" ; Lot No. 66722610 ; Serial No. 50066722610005\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611001\" ; Lot No. 66722611 ; Serial No. 50066722611001\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611002\" ; Lot No. 66722611 ; Serial No. 50066722611002\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611003\" ; Lot No. 66722611 ; Serial No. 50066722611003\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611004\" ; Lot No. 66722611 ; Serial No. 50066722611004\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611005\" ; Lot No. 66722611 ; Serial No. 50066722611005\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611006\" ; Lot No. 66722611 ; Serial No. 50066722611006\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611007\" ; Lot No. 66722611 ; Serial No. 50066722611007\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611008\" ; Lot No. 66722611 ; Serial No. 50066722611008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611009\" ; Lot No. 66722611 ; Serial No. 50066722611009\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240410(10)66722611(21)50066722611010\" ; Lot No. 66722611 ; Serial No. 50066722611010\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892001\" ; Lot No. 66742892 ; Serial No. 50066742892001\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892002\" ; Lot No. 66742892 ; Serial No. 50066742892002\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892003\" ; Lot No. 66742892 ; Serial No. 50066742892003\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892004\" ; Lot No. 66742892 ; Serial No. 50066742892004\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892005\" ; Lot No. 66742892 ; Serial No. 50066742892005\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892006\" ; Lot No. 66742892 ; Serial No. 50066742892006\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892007\" ; Lot No. 66742892 ; Serial No. 50066742892007\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892008\" ; Lot No. 66742892 ; Serial No. 50066742892008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892009\" ; Lot No. 66742892 ; Serial No. 50066742892009\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892010\" ; Lot No. 66742892 ; Serial No. 50066742892010\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240422(10)66742892(21)50066742892016\" ; Lot No. 66742892 ; Serial No. 50066742892016\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893001\" ; Lot No. 66742893 ; Serial No. 50066742893001\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893002\" ; Lot No. 66742893 ; Serial No. 50066742893002\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893003\" ; Lot No. 66742893 ; Serial No. 50066742893003\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893004\" ; Lot No. 66742893 ; Serial No. 50066742893004\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893005\" ; Lot No. 66742893 ; Serial No. 50066742893005\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893006\" ; Lot No. 66742893 ; Serial No. 50066742893006\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893007\" ; Lot No. 66742893 ; Serial No. 50066742893007\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893008\" ; Lot No. 66742893 ; Serial No. 50066742893008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893009\" ; Lot No. 66742893 ; Serial No. 50066742893009\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893010\" ; Lot No. 66742893 ; Serial No. 50066742893010\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893011\" ; Lot No. 66742893 ; Serial No. 50066742893011\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893012\" ; Lot No. 66742893 ; Serial No. 50066742893012\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893013\" ; Lot No. 66742893 ; Serial No. 50066742893013\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893014\" ; Lot No. 66742893 ; Serial No. 50066742893014\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893015\" ; Lot No. 66742893 ; Serial No. 50066742893015\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893016\" ; Lot No. 66742893 ; Serial No. 50066742893016\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893017\" ; Lot No. 66742893 ; Serial No. 50066742893017\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893018\" ; Lot No. 66742893 ; Serial No. 50066742893018\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893019\" ; Lot No. 66742893 ; Serial No. 50066742893019\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240423(10)66742893(21)50066742893020\" ; Lot No. 66742893 ; Serial No. 50066742893020\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087002\" ; Lot No. 66751087 ; Serial No. 50066751087002\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087003\" ; Lot No. 66751087 ; Serial No. 50066751087003\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087004\" ; Lot No. 66751087 ; Serial No. 50066751087004\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087007\" ; Lot No. 66751087 ; Serial No. 50066751087007\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087008\" ; Lot No. 66751087 ; Serial No. 50066751087008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087009\" ; Lot No. 66751087 ; Serial No. 50066751087009\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087010\" ; Lot No. 66751087 ; Serial No. 50066751087010\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087011\" ; Lot No. 66751087 ; Serial No. 50066751087011\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087012\" ; Lot No. 66751087 ; Serial No. 50066751087012\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087013\" ; Lot No. 66751087 ; Serial No. 50066751087013\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087014\" ; Lot No. 66751087 ; Serial No. 50066751087014\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087016\" ; Lot No. 66751087 ; Serial No. 50066751087016\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087017\" ; Lot No. 66751087 ; Serial No. 50066751087017\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087018\" ; Lot No. 66751087 ; Serial No. 50066751087018\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240528(10)66751087(21)50066751087019\" ; Lot No. 66751087 ; Serial No. 50066751087019\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240723(10)66848797(21)50066848797005\" ; Lot No. 66848797 ; Serial No. 50066848797005\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240723(10)66848797(21)50066848797007\" ; Lot No. 66848797 ; Serial No. 50066848797007\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240723(10)66848797(21)50066848797008\" ; Lot No. 66848797 ; Serial No. 50066848797008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240723(10)66848797(21)50066848797014\" ; Lot No. 66848797 ; Serial No. 50066848797014\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240723(10)66848797(21)50066848797015\" ; Lot No. 66848797 ; Serial No. 50066848797015\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799001\" ; Lot No. 66848799 ; Serial No. 50066848799001\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799002\" ; Lot No. 66848799 ; Serial No. 50066848799002\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799003\" ; Lot No. 66848799 ; Serial No. 50066848799003\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799004\" ; Lot No. 66848799 ; Serial No. 50066848799004\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799005\" ; Lot No. 66848799 ; Serial No. 50066848799005\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799006\" ; Lot No. 66848799 ; Serial No. 50066848799006\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799007\" ; Lot No. 66848799 ; Serial No. 50066848799007\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799008\" ; Lot No. 66848799 ; Serial No. 50066848799008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799009\" ; Lot No. 66848799 ; Serial No. 50066848799009\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799010\" ; Lot No. 66848799 ; Serial No. 50066848799010\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799011\" ; Lot No. 66848799 ; Serial No. 50066848799011\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799012\" ; Lot No. 66848799 ; Serial No. 50066848799012\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799013\" ; Lot No. 66848799 ; Serial No. 50066848799013\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799014\" ; Lot No. 66848799 ; Serial No. 50066848799014\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799015\" ; Lot No. 66848799 ; Serial No. 50066848799015\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799016\" ; Lot No. 66848799 ; Serial No. 50066848799016\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799017\" ; Lot No. 66848799 ; Serial No. 50066848799017\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799018\" ; Lot No. 66848799 ; Serial No. 50066848799018\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799019\" ; Lot No. 66848799 ; Serial No. 50066848799019\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240730(10)66848799(21)50066848799020\" ; Lot No. 66848799 ; Serial No. 50066848799020\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330010\" ; Lot No. 66870330 ; Serial No. 50066870330010\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330011\" ; Lot No. 66870330 ; Serial No. 50066870330011\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330012\" ; Lot No. 66870330 ; Serial No. 50066870330012\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330013\" ; Lot No. 66870330 ; Serial No. 50066870330013\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330014\" ; Lot No. 66870330 ; Serial No. 50066870330014\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330015\" ; Lot No. 66870330 ; Serial No. 50066870330015\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330016\" ; Lot No. 66870330 ; Serial No. 50066870330016\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330017\" ; Lot No. 66870330 ; Serial No. 50066870330017\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330018\" ; Lot No. 66870330 ; Serial No. 50066870330018\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240808(10)66870330(21)50066870330019\" ; Lot No. 66870330 ; Serial No. 50066870330019\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240905(10)66959543(21)50066959543009\" ; Lot No. 66959543 ; Serial No. 50066959543009\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240910(10)66969025(21)50066969025001\" ; Lot No. 66969025 ; Serial No. 50066969025001\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240910(10)66969025(21)50066969025006\" ; Lot No. 66969025 ; Serial No. 50066969025006\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240910(10)66969025(21)50066969025010\" ; Lot No. 66969025 ; Serial No. 50066969025010\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240910(10)66969025(21)50066969025011\" ; Lot No. 66969025 ; Serial No. 50066969025011\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240910(10)66969025(21)50066969025016\" ; Lot No. 66969025 ; Serial No. 50066969025016\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)240918(10)66969027(21)50066969027008\" ; Lot No. 66969027 ; Serial No. 50066969027008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241021(10)66995371(21)50066995371013\" ; Lot No. 66995371 ; Serial No. 50066995371013\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241021(10)66995371(21)50066995371014\" ; Lot No. 66995371 ; Serial No. 50066995371014\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046297(21)50067046297014\" ; Lot No. 67046297 ; Serial No. 50067046297014\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046298(21)50067046298014\" ; Lot No. 67046298 ; Serial No. 50067046298014\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046298(21)50067046298015\" ; Lot No. 67046298 ; Serial No. 50067046298015\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046298(21)50067046298016\" ; Lot No. 67046298 ; Serial No. 50067046298016\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046298(21)50067046298018\" ; Lot No. 67046298 ; Serial No. 50067046298018\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046298(21)50067046298019\" ; Lot No. 67046298 ; Serial No. 50067046298019\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241106(10)67046298(21)50067046298020\" ; Lot No. 67046298 ; Serial No. 50067046298020\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240003\" ; Lot No. 67071240 ; Serial No. 50067071240003\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240005\" ; Lot No. 67071240 ; Serial No. 50067071240005\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240008\" ; Lot No. 67071240 ; Serial No. 50067071240008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240011\" ; Lot No. 67071240 ; Serial No. 50067071240011\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240012\" ; Lot No. 67071240 ; Serial No. 50067071240012\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240014\" ; Lot No. 67071240 ; Serial No. 50067071240014\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241115(10)67071240(21)50067071240018\" ; Lot No. 67071240 ; Serial No. 50067071240018\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765001\" ; Lot No. 67117765 ; Serial No. 50067117765001\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765002\" ; Lot No. 67117765 ; Serial No. 50067117765002\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765003\" ; Lot No. 67117765 ; Serial No. 50067117765003\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765004\" ; Lot No. 67117765 ; Serial No. 50067117765004\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765005\" ; Lot No. 67117765 ; Serial No. 50067117765005\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765007\" ; Lot No. 67117765 ; Serial No. 50067117765007\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765008\" ; Lot No. 67117765 ; Serial No. 50067117765008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765009\" ; Lot No. 67117765 ; Serial No. 50067117765009\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765010\" ; Lot No. 67117765 ; Serial No. 50067117765010\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765011\" ; Lot No. 67117765 ; Serial No. 50067117765011\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765019\" ; Lot No. 67117765 ; Serial No. 50067117765019\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117765(21)50067117765020\" ; Lot No. 67117765 ; Serial No. 50067117765020\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117766(21)50067117766002\" ; Lot No. 67117766 ; Serial No. 50067117766002\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117766(21)50067117766007\" ; Lot No. 67117766 ; Serial No. 50067117766007\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117766(21)50067117766008\" ; Lot No. 67117766 ; Serial No. 50067117766008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117766(21)50067117766013\" ; Lot No. 67117766 ; Serial No. 50067117766013\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241207(10)67117766(21)50067117766014\" ; Lot No. 67117766 ; Serial No. 50067117766014\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768002\" ; Lot No. 67117768 ; Serial No. 50067117768002\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768004\" ; Lot No. 67117768 ; Serial No. 50067117768004\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768005\" ; Lot No. 67117768 ; Serial No. 50067117768005\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768006\" ; Lot No. 67117768 ; Serial No. 50067117768006\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768007\" ; Lot No. 67117768 ; Serial No. 50067117768007\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768008\" ; Lot No. 67117768 ; Serial No. 50067117768008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768009\" ; Lot No. 67117768 ; Serial No. 50067117768009\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768010\" ; Lot No. 67117768 ; Serial No. 50067117768010\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768011\" ; Lot No. 67117768 ; Serial No. 50067117768011\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768012\" ; Lot No. 67117768 ; Serial No. 50067117768012\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768013\" ; Lot No. 67117768 ; Serial No. 50067117768013\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768014\" ; Lot No. 67117768 ; Serial No. 50067117768014\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768015\" ; Lot No. 67117768 ; Serial No. 50067117768015\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768017\" ; Lot No. 67117768 ; Serial No. 50067117768017\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)241220(10)67117768(21)50067117768018\" ; Lot No. 67117768 ; Serial No. 50067117768018\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667001\" ; Lot No. 67482667 ; Serial No. 50067482667001\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667002\" ; Lot No. 67482667 ; Serial No. 50067482667002\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667003\" ; Lot No. 67482667 ; Serial No. 50067482667003\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667004\" ; Lot No. 67482667 ; Serial No. 50067482667004\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667005\" ; Lot No. 67482667 ; Serial No. 50067482667005\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667006\" ; Lot No. 67482667 ; Serial No. 50067482667006\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667007\" ; Lot No. 67482667 ; Serial No. 50067482667007\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667008\" ; Lot No. 67482667 ; Serial No. 50067482667008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667009\" ; Lot No. 67482667 ; Serial No. 50067482667009\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667010\" ; Lot No. 67482667 ; Serial No. 50067482667010\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667012\" ; Lot No. 67482667 ; Serial No. 50067482667012\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667013\" ; Lot No. 67482667 ; Serial No. 50067482667013\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667014\" ; Lot No. 67482667 ; Serial No. 50067482667014\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667015\" ; Lot No. 67482667 ; Serial No. 50067482667015\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667016\" ; Lot No. 67482667 ; Serial No. 50067482667016\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667017\" ; Lot No. 67482667 ; Serial No. 50067482667017\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667018\" ; Lot No. 67482667 ; Serial No. 50067482667018\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667019\" ; Lot No. 67482667 ; Serial No. 50067482667019\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250729(10)67482667(21)50067482667020\" ; Lot No. 67482667 ; Serial No. 50067482667020\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336002\" ; Lot No. 67533336 ; Serial No. 50067533336002\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336003\" ; Lot No. 67533336 ; Serial No. 50067533336003\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336004\" ; Lot No. 67533336 ; Serial No. 50067533336004\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336005\" ; Lot No. 67533336 ; Serial No. 50067533336005\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336006\" ; Lot No. 67533336 ; Serial No. 50067533336006\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336007\" ; Lot No. 67533336 ; Serial No. 50067533336007\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336008\" ; Lot No. 67533336 ; Serial No. 50067533336008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336009\" ; Lot No. 67533336 ; Serial No. 50067533336009\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336010\" ; Lot No. 67533336 ; Serial No. 50067533336010\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336012\" ; Lot No. 67533336 ; Serial No. 50067533336012\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336013\" ; Lot No. 67533336 ; Serial No. 50067533336013\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336016\" ; Lot No. 67533336 ; Serial No. 50067533336016\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336017\" ; Lot No. 67533336 ; Serial No. 50067533336017\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250808(10)67533336(21)50067533336020\" ; Lot No. 67533336 ; Serial No. 50067533336020\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250902(10)67542546(21)50067542546012\" ; Lot No. 67542546 ; Serial No. 50067542546012\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250902(10)67542546(21)50067542546018\" ; Lot No. 67542546 ; Serial No. 50067542546018\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349001\" ; Lot No. 67553349 ; Serial No. 50067553349001\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349004\" ; Lot No. 67553349 ; Serial No. 50067553349004\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349006\" ; Lot No. 67553349 ; Serial No. 50067553349006\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349007\" ; Lot No. 67553349 ; Serial No. 50067553349007\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349008\" ; Lot No. 67553349 ; Serial No. 50067553349008\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349009\" ; Lot No. 67553349 ; Serial No. 50067553349009\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349010\" ; Lot No. 67553349 ; Serial No. 50067553349010\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349011\" ; Lot No. 67553349 ; Serial No. 50067553349011\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349012\" ; Lot No. 67553349 ; Serial No. 50067553349012\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349014\" ; Lot No. 67553349 ; Serial No. 50067553349014\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349016\" ; Lot No. 67553349 ; Serial No. 50067553349016\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349017\" ; Lot No. 67553349 ; Serial No. 50067553349017\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349018\" ; Lot No. 67553349 ; Serial No. 50067553349018\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349019\" ; Lot No. 67553349 ; Serial No. 50067553349019\nModel No. 60500010100 ; UDI \"(01)00889024626454(11)250822(10)67553349(21)50067553349020\" ; Lot No. 67553349 ; Serial No. 50067553349020", "firm_fei_number": "1526350", "recalling_firm": "Zimmer Surgical Inc", "address_1": "200 W Ohio Ave", "city": "Dover", "state": "OH", "postal_code": "44622-9642", "additional_info_contact": "411 Technical Services\n800-6136131", "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.", "root_cause_description": "Under Investigation by firm", "action": "On December 30, 2025, the firm began notifying consignees through Urgent Medical Device Recall letters.\n\nThe 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.\n\nATS5000 Affected Languages:\n\nCzech, Danish, Finnish, French, Italian, Lithuanian, Norwegian, Romanian, Slovak, Slovenian, and Turkish\n\nUnaffected Languages:\n\nEnglish, Chinese (simplified), Korean, Japanese, Greek, Bulgarian, and Russian\n\nAll 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.\n\nThe 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.", "product_quantity": "206", "distribution_pattern": "International distribution to the countries of Canada and EMEA only.", "openfda": { "k_number": [ "K162365", "K012632", "K842963", "K945167", "K954201", "K900104", "K910449", "K853802", "K953953", "K871982", "K952038", "K890014", "K791759", "K860463", "K933994", "K910512", "K942303", "K940615", "K123553", "K813231", "K202919", "K860095", "K954103", "K924273", "K112874", "K841558", "K925033", "K050411", "K071140", "K880020", "K780988", "K870784", "K955552", "K840206" ], "registration_number": [ "3002907620", "3011185837", "3011277660", "3016678045", "1818910", "3007997036", "3008381116", "3014313732", "3014830562", "3006128321", "3030153385", "3011683674", "3034520", "3004905643", "3023228837", "1220351", "3015967359", "3010595915", "3032391", "3005173255", "3016764932", "3004116008", "2320762", "3012421607", "3014126909", "3009039068", "3006535925", "3013783488", "3012494290", "3033511104", "3012536737", "3010759902", "3012276218", "1048735", "2029275", "1528668", "3013730933", "2528981", "3033773618", "3025434447", "9611559", "3016445580", "3020163307", "3004727093", "3010123014", "1649518", "3010883047", "1058584", "1421307", "3030516433", "2011171", "9611283", "1822565", "3015280549", "3015225571", "3014739961", "3031887985", "3006950086", "3005698350", "3004824601", "8010482", "1018470", "3010273872", "2650143", "9613910", "3007478714", "3010291427", "3014023545", "3009605245", "3015495690", "3015207155", "3015542154", "1423537", "9680215", "9681444", "9680579", "1422634", "1526350", "3006975482", "3008264111", "1043214", "3030733800", "2184171", "3010190204", "2032098", "3013846070", "1721504", "8040278", "3016950436", "1921846", "3015309643", "3011642792", "1650907", "1720929", "3038700849", "3016965559", "3005621729", "3009056984", "8010939", "3033589330", "3031700059", "3009350690", "2648666", "1722028", "3006703573", "3045058049", "3010410654", "3003244954" ], "fei_number": [ "3002907620", "1000292048", "3011185837", "3011277660", "3016678045", "1818910", "3007997036", "3008381116", "3014313732", "3014830562", "3006128321", "3030153385", "3001236277", "3003058448", "3011683674", "3004905643", "3023228837", "1220351", "3015967359", "3010595915", "3005173255", "3016764932", "3004116008", "3004216008", "3012421607", "3014126909", "3009039068", "3006535925", "3013783488", "3012494290", "3033511104", "3012536737", "3010759902", "3012276218", "1048735", "3013730933", "2528981", "3033773618", "3025434447", "3016445580", "1000117351", "3020163307", "3004727093", "3010123014", "1000219637", "1421307", "3030516433", "3003350313", "1000136409", "2011171", "3015280549", "3002806816", "3001236905", "3015225571", "3014739961", "3031887985", "3006950086", "3005698350", "3004824601", "1018470", "3010273872", "3004574120", "3003748933", "3007478714", "3010291427", "3012599796", "3014023545", "3009605245", "2648209", "3015495690", "1000306431", "3015207155", "3015542154", "1000514656", "1000220733", "1526350", "3006975482", "3008264111", "1043214", "1000139815", "3003255513", "3030733800", "3010190204", "3013846070", "1721504", "3016950436", "1921846", "3015309643", "3011642792", "1720929", "3001084824", "3038700849", "3002299608", "3002681132", "3016965559", "3003040625", "3005621729", "3009056984", "3033589330", "3031700059", "3009350690", "3002808440", "2648666", "3006703573", "3045058049", "1000203464", "3010410654", "3003244954" ], "device_name": "Tourniquet, Pneumatic", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5910", "device_class": "1" } } ] }