| | Class 2 Device Recall Zimmer Tourniquet Systems |  |
| Date Initiated by Firm | December 24, 2025 |
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| Date Posted | January 28, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1202-2026 |
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| Recall Event ID |
98235 |
| 510(K)Number | K050411 |
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| Product Classification |
Tourniquet, pneumatic - Product Code KCY
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| 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 |
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| Code Information |
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
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| FEI Number |
1526350
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Recalling Firm/
Manufacturer |
Zimmer Surgical Inc
200 W Ohio Ave
Dover OH 44622-9642
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| For Additional Information Contact | 411 Technical Services
800-6136131 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | 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. |
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| Quantity in Commerce | 51 |
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| Distribution | International distribution to the countries of Canada and EMEA only. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = KCY
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