Class IIOngoingZ-1201-2026

Zimmer Surgical Inc recalls Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems…

Zimmer Surgical IncDover, OH, United StatesReported Feb 4, 2026 · 5 months ago

Legal News Analyst · Feb 4, 2026

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A

Lot / code information

Lot #: Code:
Model: 60500010100
UDI: (01)00889024626454(11)240410(10)66722609(21)50066722609001
Lot #: 66722609
Serial #: 50066722609001
Model: 60500010100
UDI: "(01)00889024626454(11)240410(10)66722609(21)50066722609002
Lot #: 66722609
Serial #: 50066722609002
Model: 60500010100

What the firm is doing

On December 30, 2025, the firm began notifying consignees through Urgent Medical Device Recall letters. The firm is conducting this recall in two phases. In Phase 1, which began on 12/30/2025, consignees are informed that the screen may freeze or stop responding to touch when used in certain international languages. Users may continue to use the device by utilizing the English language mode. Use of the device in an affected language is not advised, and may cause the issue to occur. ATS5000 Affected Languages: Czech, Danish, Finnish, French, Italian, Lithuanian, Norwegian, Romanian, Slovak, Slovenian, and Turkish Unaffected Languages: English, Chinese (simplified), Korean, Japanese, Greek, Bulgarian, and Russian All devices manufactured between April 2024 - September 2025 with software version v2.04 are within scope of the recall. Affected devices will require an upgrade to the new software version v2.05 when it is available in early 2026. The firm will issue a removal notice (Phase 2) once the new software version is available. Customers are instructed to not return affected devices before the initiation of Phase 2.

DistributionShow details

International distribution to the countries of Canada and EMEA only.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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