Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Single Hose with CPC Connectors Mode

FDA device recall Z-2674-2026 · posted 2026-07-02 · Open, Classified

Recall details

Recalling firm

Zimmer Surgical Inc

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.

Action taken

On June 8, 2026, the firm began notifying consignees titled "URGENT MEDICAL DEVICE RECALL." Customers were instructed to locate and quarantine affected product in their inventory. Customers may either return the affected product, or a Zimmer Biomet sales representative may remove and return the affected product on the customer's behalf. If the product has been further distributed, the distributor should notify downstream customers and accounts of the recall. All customers should ensure that affected personnel are aware of the recall. This recall is related to prior recall RES 98665, conducted to remove Mixing Bowl and Spatula due to similar issues with seal integrity.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KCY

Quantity affected

14360

Distribution

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

Date initiated

2026-06-09

Date posted

2026-07-02

Location

Dover, OH