ASP Global, LLC. recalls Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF

Recalling company

ASP Global, LLC.

Product

Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 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

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Aug 24, 2026

Reported

Oct 7, 2026

Distribution

US Nationwide distribution in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, WY.

Status

Ongoing

Quantity

5015

Lot / codes

Lot Code: Model Number: 553322 UDI-DI: (01) 00885914010532 All Lots produced from 01SEP2016 to 01MAR2023: S0922STY, R0310STY, R0801STY, Q0930STY, P0620STY, O0815STY, N0730STY, M0930STY

Company location

Austell, GA

Recall type

Voluntary: Firm initiated

Recall number

Z-0003-2027

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0003-2027 in the FDA Enforcement Report. Also see FDA recall press releases.