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Zimmer Tourniquet Systems Recalled Due to Screen Malfunction

Zimmer Surgical Inc recalled 206 A.T.S. 5000TS Tourniquet Systems on December 24, 2025. The device can freeze or become unresponsive in certain non-English language settings. This issue may delay patient care during emergencies.

Official notice
Zimmer SurgicalHealth & Personal CareMedical DevicesLot Code: Model No. 60500010100UDI (01)00889024626454(11)240410(10)66722609(21)50066722609001Lot No. 66722609

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
December 24, 2025
Status
ACTIVE
Severity
8/10

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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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.

  1. Recall announced

    December 24, 2025

  2. Reported by FDA DEVICE

    February 4, 2026

  3. RecallRadar source check

    April 13, 2026

  4. 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

  1. Check the model number on the device to confirm it is 60500010100.
  2. Verify the software version; it should be v2.04 or prior.
  3. 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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

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
+11 more
Report Date
February 4, 2026
Recall Status
ACTIVE

Related Recalls

HIGH

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Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

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