CLASS II ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report
Zimmer Tourniquet Systems A.T.S.¿ 3200TS Tourniquet Systems recalled
Zimmer Surgical is recalling Zimmer Tourniquet Systems A.T.S.¿ 3200TS Tourniquet Systems. 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-1202-2026
- 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.¿ 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
Where it was distributed
International distribution to the countries of Canada and EMEA only.
Questions about this recall
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. 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
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98235| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Zimmer Tourniquet Systems A.T.S.¿ 5000TS Tourniquet Systems recalled | Zimmer Surgical | Device Malfunction | OH |
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|---|---|---|---|---|---|
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| Device | CLASS II | Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems recalled | Zimmer Surgical | Sterility | Nationwide |
| Device | CLASS II | Zimmer Tourniquet Systems A.T.S.¿ 5000TS Tourniquet Systems recalled | Zimmer Surgical | Device Malfunction | OH |
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