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Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 10) YELLOW Model/Catalog Number: 564008 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

Class II
Recalling firm
ASP Global, LLC.
Reason for recall
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 / model / serial)
Lot Code: Model Number: 564008 UDI-DI: (01) 00885914044582 All Lots produced from 01SEP2016 to 01MAR2023: S0823STY, S0922STY, S1101STY, S1214STY, R0310STY, R0601STY, R0801STY, R1101STY, Q0301STY, Q0930STY, Q1115STY, P0325STY, P0620STY, P1015STY, N0330STY, N0730STY, M0730STY, M0930STY
Units affected
4610
Distribution pattern
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.
Firm location
Austell, GA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-0010-2027
Recall initiated
August 24, 2026
FDA classification date
October 1, 2026
FDA report date
October 7, 2026
FDA event ID
99676
Last updated on HTM Vibe
October 13, 2026
View on openFDA