Quick Facts at a Glance
- Recall Date
- December 24, 2025
- Hazard Level
- HIGH
- Brand
- Zimmer Surgical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Zimmer Surgical
- Product type
- Tourniquet Systems
- Model numbers
- 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, Serial No. 50066722609002 Model No. 60500010100, UDI "(01)00889024626454(11)240410(10)66722609(21)50066722609003", Serial No. 50066722609003 Model No. 60500010100 +8 more
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 24, 2025
Reported by FDA DEVICE
February 4, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Zimmer Surgical Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
The A.T.S. 5000TS Tourniquet Systems are used in emergency medical situations to control bleeding. Healthcare providers rely on this device to stabilize patients before more advanced treatment can be administered.
Why This Is Dangerous
The device's user interface may freeze, preventing healthcare providers from using it effectively during critical moments. This can lead to delays in securing alternate devices needed for patient care.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The potential malfunction could significantly impact patient outcomes during emergencies, highlighting the importance of having functional medical devices readily available.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device to confirm it is 60500010100.
- Verify the software version; it should be v2.04 or prior.
- Look for any recall notices sent by Zimmer Surgical Inc.
Where to find product info
The model number and software version can typically be found on the device label or packaging.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all communications with the company.
- Follow up with the company via phone or email if no response is received within a week.
- Consider filing a complaint with the FDA if the issue persists.
How to prevent similar issues
- Ensure devices are regularly updated and checked for recalls before use.
- Purchase tourniquets from reputable manufacturers with strong safety records.
- Look for devices with clear user interfaces and reliable operation.
Documentation advice
Keep records of all communications regarding the recall, including emails and letters. Save any receipts or documents related to the purchase.
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Product Details
The recall affects A.T.S. 5000TS Tourniquet Systems with model number 60500010100 and software versions v2.04 or prior. The devices were distributed internationally to Canada and EMEA only.
Key Facts
- Recall affects 206 units
- Malfunction may delay emergency treatment
- Devices distributed in Canada and EMEA
- Immediate stop-use required
- Contact Zimmer Surgical for instructions
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Safety Guide
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