FDA recall Z-2674-2026

Product

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada and EMEA.

Key facts

Status

Ongoing

Initiation date

2026-06-09

Report date

2026-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dover, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2674-2026