Asp Global, Llc.: Tourniquet, Pneumatic

Recall Summary ASP Global is recalling Expressaire Disposable Tourniquet Cuffs (model A70107011) distributed nationwide because the products are labeled with a 10-year expiration date when the actual validated shelf life is only 5 years. The cuffs, used during surgery to restrict blood flow to a patient's limb, were manufactured between September 2016 and March 2023 and may have exceeded their safe usable lifespan. This is a Class I recall, the most serious classification.

Recalling firm
ASP Global, LLC.
Product
Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 18) BLUE Model/Catalog Number: A70107011 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 I
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-08-24
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
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.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/fc1dd5c5-f360-44c5-ae98-b672754f4f1a