FDA recall Z-1201-2026

Product

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

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.

Distribution

International distribution to the countries of Canada and EMEA only.

Key facts

Status

Ongoing

Initiation date

2025-12-24

Report date

2026-02-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dover, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1201-2026