Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Cat...
FDA Device Recall #Z-1202-2026 - Class II, December 24, 2025
Recall Summary
| Recall Number | Z-1202-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 24, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer Surgical Inc |
| Location | Dover, OH |
| Product Type | Devices |
| Quantity | 51 |
Product Description
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
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.
Distribution Pattern
International distribution to the countries of Canada and EMEA only.
Lot / 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
Other Recalls from Zimmer Surgical Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2674-2026 | Class II | Brand Name: Sterile Tourniquet Hoses Product N... | Jun 9, 2026 |
| Z-2673-2026 | Class II | Brand Name: Sterile Tourniquet Hoses Product N... | Jun 9, 2026 |
| Z-1201-2026 | Class II | Brand Name: Zimmer Tourniquet Systems Product ... | Dec 24, 2025 |
| Z-0925-2026 | Class II | Zimmer Dermatome AN, Model/Catalog Number: 8871... | Nov 24, 2025 |
| Z-0924-2026 | Class II | Zimmer Air Dermatome, Model/Catalog Number: 008... | Nov 24, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.