Home/Recalls/FDA-Z-1201-2026
FDA DevicesClass II

Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet S...

Published: February 4, 2026Recall ID: Z-1201-2026Category: devicesCountry: US

Reason for Recall / Hazard

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.

Product Description & Identification

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

Affected Products

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

Additional Source Details

FieldValue
CityDover
StateOH
Event id98235
Address 1200 W Ohio Ave
Address 2N/A
Code infoLot 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... [TRUNCATED]
Postal code44622-9642
Report date20260204
Product typeDevices
Product quantity206
Reason for recallDevice 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20251224
Initial firm notificationLetter
Center classification date20260128

Overview

  • Recalling FirmZimmer Surgical Inc
  • StatusOngoing
  • Risk LevelClass II
  • DistributionInternational distribution to the countries of Canada and EMEA only.
Official Agency Alert