Official recall notice

FDA DeviceClass IINotable

Disposable Tourniquet Cuff Recall (Oct 2026) – ASP Global

Product: Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-Line, Green Model/Catalog Number: ASP-564014 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. It is non-invasive device. Tourniquet Cuffs are intended for use in surgical procedures that requires the interruption of blood flow and clear visualization of the operative field. Component: No

Recall date
2026-10-07
FDA class
Class II

Why it was recalled

Hazard

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

One email a week when there are new recalls. Confirm by email; unsubscribe anytime.

Product description

Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.

Affected products

Lot Code: Model Number: ASP-564014 UDI-DI: (01) 00840216106796 All Lots produced from 01SEP2016 to 01MAR2023: P1015STY, P1215STY, O0815STY, O1020STY, N0330STY, N0530STY, M0130STY, M0430STY, M0730STY, M0930STY, M1015STY, M1101STY, M1115STY, L0310STY, L0325STY

Related Recalls