FDA recall, , Moderate risk
Zimmer Tourniquet Systems A.T.S. 5000TS and 3200TS Tourniquet Systems
Zimmer A.T.S. 5000TS and 3200TS Tourniquet Systems may freeze or become unresponsive to touch in certain non-English language settings.
Summary by Recall Canary from the FDA notice
What happened
Zimmer Surgical Inc of Dover, Ohio, recalled A.T.S. 3200TS and A.T.S. 5000TS Tourniquet Systems on December 24, 2025, because the device user interface may freeze or become unresponsive to touch when operating in certain non-English language settings, which may cause delay or extension while an alternate device is located. The recall was added to the FDA's Enforcement Report on January 28, 2026, and distributed internationally to Canada and EMEA only.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Zimmer Tourniquet Systems A.T.S.¿ 3200TS Tourniquet Systems
- UDI-DI
- 60320010100
- 00889024626447
- 67505739
- 32067505739001
- 32067505739003
- 32067505739004
- 32067505739005
- 32067505739006
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- 67508816
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- 67508820
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- 32067508820019
- 32067508820020
- Model/Catalog number
- 60320010100
- Software version
- Software version v2.06 or prior are within scope of the recall for A.T.S.¿ 3200TS
Zimmer Tourniquet Systems A.T.S.¿ 5000TS Tourniquet Systems
- UDI-DI
- 60500010100
- 00889024626454
- 66722609
- 50066722609001
- 50066722609002
- 50066722609003
- 50066722609004
- 50066722609005
- 66722610
- 50066722610001
- 50066722610002
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- 50066722610005
- 66722611
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- 66742892
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- 66742893
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- 50067553349019
- 50067553349020
- Model/Catalog number
- 60500010100
- Software version
- Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS
Recall details
- Company began the recall
- Sold in
International distribution to the countries of Canada and EMEA only.
- Company
- Zimmer Surgical IncDover, Ohio
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98235
- Recall numbers
- Z-1201-2026 to Z-1202-2026
All recalls from Zimmer Surgical Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
