FDA-Device2026-10-07Class IIMISBRANDING
Expressaire Disposable Tourniquet Cuff recalled for incorrect expiration dating
What this means
Expressaire Disposable Tourniquet Cuffs (model 564012) manufactured between September 2016 and March 2023 were labeled with a 10-year shelf life, but the actual validated shelf life is only 5 years. This means some units in circulation may have passed their true expiration date without being identified as expired.
- Check tourniquet cuffs for lot codes S0922STY through M1230STY (manufactured Sept 2016–March 2023)
- Verify the actual expiration date is no more than 5 years from the manufacture date on the package
- Quarantine or discard any cuffs that have exceeded 5 years since manufacture
- Contact your supplier or ASP Global if you have questions about affected inventory
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
26810
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 10) BLUE Model/Catalog Number: 564012 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-0014-2027More ASP Global recalls
- FDA-Device2026-10-07ASP Global disposable tourniquet cuff recalled for incorrect expiration dating
- FDA-Device2026-10-07ASP Global MPR tourniquet cuff recalled for incorrect expiration dating
- FDA-Device2026-10-07Expressaire disposable tourniquet cuffs recalled for incorrect expiration dating
- FDA-Device2026-10-07Expressaire Disposable Tourniquet Cuff recalled for incorrect expiration dating
- FDA-Device2026-10-07Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-Line, Green Model/Catalog Number: ASP-564015 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 opera
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