FDA-Device2026-10-07Class IIMISBRANDING

ASP Global Expressaire disposable tourniquet cuff recalled for incorrect expiration dating

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

ASP Global's Expressaire disposable tourniquet cuffs manufactured between September 2016 and March 2023 are labeled with a 10-year shelf life, but the actual validated shelf life is only 5 years. Hospitals and surgical centers may unknowingly use expired cuffs in patient procedures.

  • Check your inventory for Expressaire tourniquet cuffs (model 553322) manufactured between September 2016 and March 2023.
  • Verify the expiration date on your cuffs against a 5-year shelf life from the manufacturing date, not the 10-year date on the label.
  • Remove any expired cuffs from circulation and contact ASP Global or your supplier for replacement or credit.
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The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
5015
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0003-2027

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