FDA-Device2026-10-07Class IIMISBRANDING
Expressaire Disposable Tourniquet Cuff recalled for incorrect expiration dating
What this means
Expressaire Disposable Tourniquet Cuffs manufactured between September 2016 and March 2023 were labeled with a 10-year shelf life, but the correct validated shelf life is only 5 years. This means some of these cuffs may have been used past their actual expiration date, potentially affecting sterility and performance during surgery.
- Check tourniquet cuffs for lot codes S0922STY through M0930STY produced between September 2016 and March 2023
- Do not use cuffs manufactured more than 5 years ago, regardless of the label
- Contact your supplier or ASP Global, LLC. for guidance on affected inventory
- Report any adverse events to the FDA MedWatch program
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
2244
Manufactured in
7800 Third Flag Pkwy, Austell, GA, United States
Products
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 12) GREEN Model/Catalog Number: A70107013 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-0034-2027More 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-Device2026-10-07Brand 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
- FDA-Device2026-10-07ASP Global MPR tourniquet cuff recalled for incorrect expiration dating
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