CLASS II ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report
Zimmer Tourniquet Systems A.T.S.¿ 5000TS Tourniquet Systems recalled
Zimmer Surgical is recalling Zimmer Tourniquet Systems A.T.S.¿ 5000TS Tourniquet Systems, distributed nationwide in the US. The recall was initiated on 24 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1201-2026
- FDA event ID
- 98235
- Recalling firm
- Zimmer Surgical, Dover, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Dec 2025
- FDA classified
- 28 Jan 2026
- Reported
- 4 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 24 Dec 2025 | Recall initiated by company | |
| 28 Jan 2026 | Classified by FDA | +35 days |
| 4 Feb 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
International distribution to the countries of Canada and EMEA only.
Questions about this recall
Is Zimmer Tourniquet Systems A.T.S.¿ 5000TS Tourniquet Systems recalled?
Yes. Zimmer Surgical recalled Zimmer Tourniquet Systems A.T.S.¿ 5000TS Tourniquet Systems on 24 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1201-2026.
Why was it recalled?
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.
Which lots are affected?
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. 66722610 ; Serial No. 50066722610004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722610(21)50066722610005" ; Lot No. 66722610 ; Serial No. 50066722610005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611001" ; Lot No. 66722611 ; Serial No. 50066722611001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611002" ; Lot No. 66722611 ; Serial No. 50066722611002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611003" ; Lot No. 66722611 ; Serial No. 50066722611003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611004" ; Lot No. 66722611 ; Serial No. 50066722611004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611005" ; Lot No. 66722611 ; Serial No. 50066722611005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611006" ; Lot No. 66722611 ; Serial No. 50066722611006 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611007" ; Lot No. 66722611 ; Serial No. 50066722611007 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611008" ; Lot No. 66722611 ; Serial No. 50066722611008 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611009" ; Lot No. 66722611 ; Serial No. 50066722611009 Model No. 60500010100 ; UDI "(01)00889024626454(11)240410(10)66722611(21)50066722611010" ; Lot No. 66722611 ; Serial No. 50066722611010 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892001" ; Lot No. 66742892 ; Serial No. 50066742892001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892002" ; Lot No. 66742892 ; Serial No. 50066742892002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892003" ; Lot No. 66742892 ; Serial No. 50066742892003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892004" ; Lot No. 66742892 ; Serial No. 50066742892004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892005" ; Lot No. 66742892 ; Serial No. 50066742892005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892006" ; Lot No. 66742892 ; Serial No. 50066742892006 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892007" ; Lot No. 66742892 ; Serial No. 50066742892007 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892008" ; Lot No. 66742892 ; Serial No. 50066742892008 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892009" ; Lot No. 66742892 ; Serial No. 50066742892009 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892010" ; Lot No. 66742892 ; Serial No. 50066742892010 Model No. 60500010100 ; UDI "(01)00889024626454(11)240422(10)66742892(21)50066742892016" ; Lot No. 66742892 ; Serial No. 50066742892016 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893001" ; Lot No. 66742893 ; Serial No. 50066742893001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893002" ; Lot No. 66742893 ; Serial No. 50066742893002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893003" ; Lot No. 66742893 ; Serial No. 50066742893003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893004" ; Lot No. 66742893 ; Serial No. 50066742893004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893005" ; Lot No. 66742893 ; Serial No. 50066742893005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893006" ; Lot No. 66742893 ; Serial No. 50066742893006 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893007" ; Lot No. 66742893 ; Serial No. 50066742893007 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893008" ; Lot No. 66742893 ; Serial No. 50066742893008 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893009" ; Lot No. 66742893 ; Serial No. 50066742893009 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893010" ; Lot No. 66742893 ; Serial No. 50066742893010 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893011" ; Lot No. 66742893 ; Serial No. 50066742893011 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893012" ; Lot No. 66742893 ; Serial No. 50066742893012 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893013" ; Lot No. 66742893 ; Serial No. 50066742893013 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893014" ; Lot No. 66742893 ; Serial No. 50066742893014 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893015" ; Lot No. 66742893 ; Serial No. 50066742893015 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893016" ; Lot No. 66742893 ; Serial No. 50066742893016 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893017" ; Lot No. 66742893 ; Serial No. 50066742893017 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893018" ; Lot No. 66742893 ; Serial No. 50066742893018 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893019" ; Lot No. 66742893 ; Serial No. 50066742893019 Model No. 60500010100 ; UDI "(01)00889024626454(11)240423(10)66742893(21)50066742893020" ; Lot No. 66742893 ; Serial No. 50066742893020 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087002" ; Lot No. 66751087 ; Serial No. 50066751087002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087003" ; Lot No. 66751087 ; Serial No. 50066751087003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087004" ; Lot No. 66751087 ; Serial No. 50066751087004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087007" ; Lot No. 66751087 ; Serial No. 50066751087007 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087008" ; Lot No. 66751087 ; Serial No. 50066751087008 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087009" ; Lot No. 66751087 ; Serial No. 50066751087009 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087010" ; Lot No. 66751087 ; Serial No. 50066751087010 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087011" ; Lot No. 66751087 ; Serial No. 50066751087011 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087012" ; Lot No. 66751087 ; Serial No. 50066751087012 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087013" ; Lot No. 66751087 ; Serial No. 50066751087013 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087014" ; Lot No. 66751087 ; Serial No. 50066751087014 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087016" ; Lot No. 66751087 ; Serial No. 50066751087016 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087017" ; Lot No. 66751087 ; Serial No. 50066751087017 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087018" ; Lot No. 66751087 ; Serial No. 50066751087018 Model No. 60500010100 ; UDI "(01)00889024626454(11)240528(10)66751087(21)50066751087019" ; Lot No. 66751087 ; Serial No. 50066751087019 Model No. 60500010100 ; UDI "(01)00889024626454(11)240723(10)66848797(21)50066848797005" ; Lot No. 66848797 ; Serial No. 50066848797005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240723(10)66848797(21)50066848797007" ; Lot No. 66848797 ; Serial No. 50066848797007 Model No. 60500010100 ; UDI "(01)00889024626454(11)240723(10)66848797(21)50066848797008" ; Lot No. 66848797 ; Serial No. 50066848797008 Model No. 60500010100 ; UDI "(01)00889024626454(11)240723(10)66848797(21)50066848797014" ; Lot No. 66848797 ; Serial No. 50066848797014 Model No. 60500010100 ; UDI "(01)00889024626454(11)240723(10)66848797(21)50066848797015" ; Lot No. 66848797 ; Serial No. 50066848797015 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799001" ; Lot No. 66848799 ; Serial No. 50066848799001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799002" ; Lot No. 66848799 ; Serial No. 50066848799002 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799003" ; Lot No. 66848799 ; Serial No. 50066848799003 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799004" ; Lot No. 66848799 ; Serial No. 50066848799004 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799005" ; Lot No. 66848799 ; Serial No. 50066848799005 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799006" ; Lot No. 66848799 ; Serial No. 50066848799006 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799007" ; Lot No. 66848799 ; Serial No. 50066848799007 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799008" ; Lot No. 66848799 ; Serial No. 50066848799008 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799009" ; Lot No. 66848799 ; Serial No. 50066848799009 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799010" ; Lot No. 66848799 ; Serial No. 50066848799010 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799011" ; Lot No. 66848799 ; Serial No. 50066848799011 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799012" ; Lot No. 66848799 ; Serial No. 50066848799012 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799013" ; Lot No. 66848799 ; Serial No. 50066848799013 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799014" ; Lot No. 66848799 ; Serial No. 50066848799014 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799015" ; Lot No. 66848799 ; Serial No. 50066848799015 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799016" ; Lot No. 66848799 ; Serial No. 50066848799016 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799017" ; Lot No. 66848799 ; Serial No. 50066848799017 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799018" ; Lot No. 66848799 ; Serial No. 50066848799018 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799019" ; Lot No. 66848799 ; Serial No. 50066848799019 Model No. 60500010100 ; UDI "(01)00889024626454(11)240730(10)66848799(21)50066848799020" ; Lot No. 66848799 ; Serial No. 50066848799020 Model No. 60500010100 ; UDI "(01)00889024626454(11)240808(10)66870330(21)50066870330010" ; Lot No. 66870330 ; Serial No. 50066870330010 Model No. 60500010100 ; UDI "(01)00889024626454(11)240808(10)66870330(21)50066870330011" ; Lot No. 66870330 ; Serial No. 50066870330011 Model No. 60500010100 ; UDI "(01)00889024626454(11)240808(10)66870330(21)50066870330012" ; Lot No. 66870330 ; Serial No. 50066870330012 Model No. 60500010100 ; UDI "(01)00889024626454(11)240808(10)66870330(21)50066870330013" ; Lot No. 66870330 ; Serial No. 50066870330013 Model No. 60500010100 ; UDI "(01)00889024626454(11)240808(10)66870330(21)50066870330014" ; Lot No. 66870330 ; Serial No. 50066870330014 Model No. 60500010100 ; UDI "(01)00889024626454(11)240808(10)66870330(21)50066870330015" ; Lot No. 66870330 ; Serial No. 50066870330015 Model No. 60500010100 ; UDI "(01)00889024626454(11)240808(10)66870330(21)50066870330016" ; Lot No. 66870330 ; Serial No. 50066870330016 Model No. 60500010100 ; UDI "(01)00889024626454(11)240808(10)66870330(21)50066870330017" ; Lot No. 66870330 ; Serial No. 50066870330017 Model No. 60500010100 ; UDI "(01)00889024626454(11)240808(10)66870330(21)50066870330018" ; Lot No. 66870330 ; Serial No. 50066870330018 Model No. 60500010100 ; UDI "(01)00889024626454(11)240808(10)66870330(21)50066870330019" ; Lot No. 66870330 ; Serial No. 50066870330019 Model No. 60500010100 ; UDI "(01)00889024626454(11)240905(10)66959543(21)50066959543009" ; Lot No. 66959543 ; Serial No. 50066959543009 Model No. 60500010100 ; UDI "(01)00889024626454(11)240910(10)66969025(21)50066969025001" ; Lot No. 66969025 ; Serial No. 50066969025001 Model No. 60500010100 ; UDI "(01)00889024626454(11)240910(10)66969025(21)50066969025006" ; Lot No. 66969025 ; Serial No. 50066969025006 Model No. 60500010100 ; UDI "(01)00889024626454(11)240910(10)66969025(21)50066969025010" ; Lot No. 66969025 ; Serial No. 50066969025010 Model No. 60500010100 ; UDI "(01)00889024626454(11)240910(10)66969025(21)50066969025011" ; Lot No. 66969025 ; Serial No. 50066969025011 Model No. 60500010100 ; UDI "(01)00889024626454(11)240910(10)66969025(21)50066969025016" ; Lot No. 66969025 ; Serial No. 50066969025016 Model No. 60500010100 ; UDI "(01)00889024626454(11)240918(10)66969027(21)50066969027008" ; Lot No. 66969027 ; Serial No. 50066969027008 Model No. 60500010100 ; UDI "(01)00889024626454(11)241021(10)66995371(21)50066995371013" ; Lot No. 66995371 ; Serial No. 50066995371013 Model No. 60500010100 ; UDI "(01)00889024626454(11)241021(10)66995371(21)50066995371014" ; Lot No. 66995371 ; Serial No. 50066995371014 Model No. 60500010100 ; UDI "(01)00889024626454(11)241106(10)67046297(21)50067046297014" ; Lot No. 67046297 ; Serial No. 50067046297014 Model No. 60500010100 ; UDI "(01)00889024626454(11)241106(10)67046298(21)50067046298014" ; Lot No. 67046298 ; Serial No. 50067046298014 Model No. 60500010100 ; UDI "(01)00889024626454(11)241106(10)67046298(21)50067046298015" ; Lot No. 67046298 ; Serial No. 50067046298015 Model No. 60500010100 ; UDI "(01)00889024626454(11)241106(10)67046298(21)50067046298016" ; Lot No. 67046298 ; Serial No. 50067046298016 Model No. 60500010100 ; UDI "(01)00889024626454(11)241106(10)67046298(21)50067046298018" ; Lot No. 67046298 ; Serial No. 50067046298018 Model No. 60500010100 ; UDI "(01)00889024626454(11)241106(10)67046298(21)50067046298019" ; Lot No. 67046298 ; Serial No. 50067046298019 Model No. 60500010100 ; UDI "(01)00889024626454(11)241106(10)67046298(21)50067046298020" ; Lot No. 67046298 ; Serial No. 50067046298020 Model No. 60500010100 ; UDI "(01)00889024626454(11)241115(10)67071240(21)50067071240003" ; Lot No. 67071240 ; Serial No. 50067071240003 Model No. 60500010100 ; UDI "(01)00889024626454(11)241115(10)67071240(21)50067071240005" ; Lot No. 67071240 ; Serial No. 50067071240005 Model No. 60500010100 ; UDI "(01)00889024626454(11)241115(10)67071240(21)50067071240008" ; Lot No. 67071240 ; Serial No. 50067071240008 Model No. 60500010100 ; UDI "(01)00889024626454(11)241115(10)67071240(21)50067071240011" ; Lot No. 67071240 ; Serial No. 50067071240011 Model No. 60500010100 ; UDI "(01)00889024626454(11)241115(10)67071240(21)50067071240012" ; Lot No. 67071240 ; Serial No. 50067071240012 Model No. 60500010100 ; UDI "(01)00889024626454(11)241115(10)67071240(21)50067071240014" ; Lot No. 67071240 ; Serial No. 50067071240014 Model No. 60500010100 ; UDI "(01)00889024626454(11)241115(10)67071240(21)50067071240018" ; Lot No. 67071240 ; Serial No. 50067071240018 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117765(21)50067117765001" ; Lot No. 67117765 ; Serial No. 50067117765001 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117765(21)50067117765002" ; Lot No. 67117765 ; Serial No. 50067117765002 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117765(21)50067117765003" ; Lot No. 67117765 ; Serial No. 50067117765003 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117765(21)50067117765004" ; Lot No. 67117765 ; Serial No. 50067117765004 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117765(21)50067117765005" ; Lot No. 67117765 ; Serial No. 50067117765005 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117765(21)50067117765007" ; Lot No. 67117765 ; Serial No. 50067117765007 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117765(21)50067117765008" ; Lot No. 67117765 ; Serial No. 50067117765008 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117765(21)50067117765009" ; Lot No. 67117765 ; Serial No. 50067117765009 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117765(21)50067117765010" ; Lot No. 67117765 ; Serial No. 50067117765010 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117765(21)50067117765011" ; Lot No. 67117765 ; Serial No. 50067117765011 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117765(21)50067117765019" ; Lot No. 67117765 ; Serial No. 50067117765019 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117765(21)50067117765020" ; Lot No. 67117765 ; Serial No. 50067117765020 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117766(21)50067117766002" ; Lot No. 67117766 ; Serial No. 50067117766002 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117766(21)50067117766007" ; Lot No. 67117766 ; Serial No. 50067117766007 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117766(21)50067117766008" ; Lot No. 67117766 ; Serial No. 50067117766008 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117766(21)50067117766013" ; Lot No. 67117766 ; Serial No. 50067117766013 Model No. 60500010100 ; UDI "(01)00889024626454(11)241207(10)67117766(21)50067117766014" ; Lot No. 67117766 ; Serial No. 50067117766014 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768002" ; Lot No. 67117768 ; Serial No. 50067117768002 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768004" ; Lot No. 67117768 ; Serial No. 50067117768004 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768005" ; Lot No. 67117768 ; Serial No. 50067117768005 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768006" ; Lot No. 67117768 ; Serial No. 50067117768006 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768007" ; Lot No. 67117768 ; Serial No. 50067117768007 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768008" ; Lot No. 67117768 ; Serial No. 50067117768008 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768009" ; Lot No. 67117768 ; Serial No. 50067117768009 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768010" ; Lot No. 67117768 ; Serial No. 50067117768010 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768011" ; Lot No. 67117768 ; Serial No. 50067117768011 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768012" ; Lot No. 67117768 ; Serial No. 50067117768012 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768013" ; Lot No. 67117768 ; Serial No. 50067117768013 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768014" ; Lot No. 67117768 ; Serial No. 50067117768014 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768015" ; Lot No. 67117768 ; Serial No. 50067117768015 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768017" ; Lot No. 67117768 ; Serial No. 50067117768017 Model No. 60500010100 ; UDI "(01)00889024626454(11)241220(10)67117768(21)50067117768018" ; Lot No. 67117768 ; Serial No. 50067117768018 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667001" ; Lot No. 67482667 ; Serial No. 50067482667001 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667002" ; Lot No. 67482667 ; Serial No. 50067482667002 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667003" ; Lot No. 67482667 ; Serial No. 50067482667003 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667004" ; Lot No. 67482667 ; Serial No. 50067482667004 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667005" ; Lot No. 67482667 ; Serial No. 50067482667005 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667006" ; Lot No. 67482667 ; Serial No. 50067482667006 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667007" ; Lot No. 67482667 ; Serial No. 50067482667007 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667008" ; Lot No. 67482667 ; Serial No. 50067482667008 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667009" ; Lot No. 67482667 ; Serial No. 50067482667009 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667010" ; Lot No. 67482667 ; Serial No. 50067482667010 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667012" ; Lot No. 67482667 ; Serial No. 50067482667012 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667013" ; Lot No. 67482667 ; Serial No. 50067482667013 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667014" ; Lot No. 67482667 ; Serial No. 50067482667014 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667015" ; Lot No. 67482667 ; Serial No. 50067482667015 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667016" ; Lot No. 67482667 ; Serial No. 50067482667016 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667017" ; Lot No. 67482667 ; Serial No. 50067482667017 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667018" ; Lot No. 67482667 ; Serial No. 50067482667018 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667019" ; Lot No. 67482667 ; Serial No. 50067482667019 Model No. 60500010100 ; UDI "(01)00889024626454(11)250729(10)67482667(21)50067482667020" ; Lot No. 67482667 ; Serial No. 50067482667020 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336002" ; Lot No. 67533336 ; Serial No. 50067533336002 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336003" ; Lot No. 67533336 ; Serial No. 50067533336003 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336004" ; Lot No. 67533336 ; Serial No. 50067533336004 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336005" ; Lot No. 67533336 ; Serial No. 50067533336005 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336006" ; Lot No. 67533336 ; Serial No. 50067533336006 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336007" ; Lot No. 67533336 ; Serial No. 50067533336007 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336008" ; Lot No. 67533336 ; Serial No. 50067533336008 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336009" ; Lot No. 67533336 ; Serial No. 50067533336009 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336010" ; Lot No. 67533336 ; Serial No. 50067533336010 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336012" ; Lot No. 67533336 ; Serial No. 50067533336012 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336013" ; Lot No. 67533336 ; Serial No. 50067533336013 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336016" ; Lot No. 67533336 ; Serial No. 50067533336016 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336017" ; Lot No. 67533336 ; Serial No. 50067533336017 Model No. 60500010100 ; UDI "(01)00889024626454(11)250808(10)67533336(21)50067533336020" ; Lot No. 67533336 ; Serial No. 50067533336020 Model No. 60500010100 ; UDI "(01)00889024626454(11)250902(10)67542546(21)50067542546012" ; Lot No. 67542546 ; Serial No. 50067542546012 Model No. 60500010100 ; UDI "(01)00889024626454(11)250902(10)67542546(21)50067542546018" ; Lot No. 67542546 ; Serial No. 50067542546018 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349001" ; Lot No. 67553349 ; Serial No. 50067553349001 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349004" ; Lot No. 67553349 ; Serial No. 50067553349004 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349006" ; Lot No. 67553349 ; Serial No. 50067553349006 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349007" ; Lot No. 67553349 ; Serial No. 50067553349007 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349008" ; Lot No. 67553349 ; Serial No. 50067553349008 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349009" ; Lot No. 67553349 ; Serial No. 50067553349009 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349010" ; Lot No. 67553349 ; Serial No. 50067553349010 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349011" ; Lot No. 67553349 ; Serial No. 50067553349011 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349012" ; Lot No. 67553349 ; Serial No. 50067553349012 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349014" ; Lot No. 67553349 ; Serial No. 50067553349014 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349016" ; Lot No. 67553349 ; Serial No. 50067553349016 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349017" ; Lot No. 67553349 ; Serial No. 50067553349017 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349018" ; Lot No. 67553349 ; Serial No. 50067553349018 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349019" ; Lot No. 67553349 ; Serial No. 50067553349019 Model No. 60500010100 ; UDI "(01)00889024626454(11)250822(10)67553349(21)50067553349020" ; Lot No. 67553349 ; Serial No. 50067553349020
Where was it sold?
International distribution to the countries of Canada and EMEA only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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