PlainRecordsFDA · Medical device recall
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS… and 1 more product
- Date
- Feb. 4, 2026
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- Zimmer Surgical Inc
- 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.
- Distribution pattern
- International distribution to the countries of Canada and EMEA only.
2 products in this recall
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number…
- 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
- Quantity
- 206
- Codes and 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. 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 …
- Recall started
- Dec. 24, 2025
- Device type
- Tourniquet, Pneumatic
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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.
- Recall number
- Z-1201-2026
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number…
- Product
- Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software version v2.06 or prior are within scope of the recall for A.T.S.¿ 3200TS Product Description: A.T.S 3200TS Tourniquet Systems Component: N/A
- Quantity
- 51
- Codes and lots
- Lot Code: Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739001" ; Lot No. 67505739 ; Serial No. 32067505739001 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739003" ; Lot No. 67505739 ; Serial No. 32067505739003 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739004" ; Lot No. 67505739 ; Serial No. 32067505739004 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739005" ; Lot No. 67505739 ; Serial No. 32067505739005 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739006" ; Lot No. 67505739 ; Serial No. 32067505739006 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739007" ; Lot No. 67505739 ; Serial No. 32067505739007 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739008" ; Lot No. 67505739 ; Serial No. 32067505739008 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739010" ; Lot No. 67505739 ; Serial No. 32067505739010 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739013" ; Lot No. 67505739 ; Serial No. 32067505739013 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739014" ; Lot No. 67505739 ; Serial No. 32067505739014 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739015" ; Lot No. 67505739 ; Serial No. 32067505739015 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739017" ; Lot No. 67505739 ; Serial No. 32067505739017 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739019" ; Lot No. 67505739 ; Serial No. 32067505739019 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67505739(21)32067505739020" ; Lot No. 67505739 ; Serial No. 32067505739020 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816001" ; Lot No. 67508816 ; Serial No. 32067508816001 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816002" ; Lot No. 67508816 ; Serial No. 32067508816002 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816003" ; Lot No. 67508816 ; Serial No. 32067508816003 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816004" ; Lot No. 67508816 ; Serial No. 32067508816004 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816005" ; Lot No. 67508816 ; Serial No. 32067508816005 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816006" ; Lot No. 67508816 ; Serial No. 32067508816006 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816007" ; Lot No. 67508816 ; Serial No. 32067508816007 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816008" ; Lot No. 67508816 ; Serial No. 32067508816008 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816009" ; Lot No. 67508816 ; Serial No. 32067508816009 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816010" ; Lot No. 67508816 ; Serial No. 32067508816010 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816012" ; Lot No. 67508816 ; Serial No. 32067508816012 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816013" ; Lot No. 67508816 ; Serial No. 32067508816013 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816014" ; Lot No. 67508816 ; Serial No. 32067508816014 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816016" ; Lot No. 67508816 ; Serial No. 32067508816016 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816017" ; Lot No. 67508816 ; Serial No. 32067508816017 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816019" ; Lot No. 67508816 ; Serial No. 32067508816019 Model No. 60320010100 ; UDI "(01)00889024626447(11)250725(10)67508816(21)32067508816020" ; Lot No. 67508816 ; Serial No. 32067508816020 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820001" ; Lot No. 67508820 ; Serial No. 32067508820001 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820002" ; Lot No. 67508820 ; Serial No. 32067508820002 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820003" ; Lot No. 67508820 ; Serial No. 32067508820003 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820004" ; Lot No. 67508820 ; Serial No. 32067508820004 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820005" ; Lot No. 67508820 ; Serial No. 32067508820005 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820006" ; Lot No. 67508820 ; Serial No. 32067508820006 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820007" ; Lot No. 67508820 ; Serial No. 32067508820007 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820008" ; Lot No. 67508820 ; Serial No. 32067508820008 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820009" ; Lot No. 67508820 ; Serial No. 32067508820009 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820010" ; Lot No. 67508820 ; Serial No. 32067508820010 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820011" ; Lot No. 67508820 ; Serial No. 32067508820011 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820012" ; Lot No. 67508820 ; Serial No. 32067508820012 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820013" ; Lot No. 67508820 ; Serial No. 32067508820013 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820014" ; Lot No. 67508820 ; Serial No. 32067508820014 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820015" ; Lot No. 67508820 ; Serial No. 32067508820015 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820016" ; Lot No. 67508820 ; Serial No. 32067508820016 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820017" ; Lot No. 67508820 ; Serial No. 32067508820017 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820018" ; Lot No. 67508820 ; Serial No. 32067508820018 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820019" ; Lot No. 67508820 ; Serial No. 32067508820019 Model No. 60320010100 ; UDI "(01)00889024626447(11)250730(10)67508820(21)32067508820020" ; Lot No. 67508820 ; Serial No. 32067508820020
- Recall started
- Dec. 24, 2025
- Device type
- Tourniquet, Pneumatic
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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.
- Recall number
- Z-1202-2026
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1201-2026, Z-1202-2026. The agency record governs; check it and the company before acting.