Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF recall (ASP Global, LLC.)
Medical deviceClass IIOngoing
Summary: ASP Global, LLC. is recalling Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 10) PLUM Model/Catalog Number: 564003 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 o. 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.
What is being recalled
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 10) PLUM Model/Catalog Number: 564003 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
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, Wyoming)
How to tell if yours is affected
Lot Code: Model Number: 564003 UDI-DI: (01) 00885914044537 All Lots produced from 01SEP2016 to 01MAR2023: S0922STY, S1101STY, Q0930STY, Q1115STY, P1015STY, M0730STY, M0930STY, M1230STY
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0006-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 24, 2026 |
| Reported | October 7, 2026 |
| Company | ASP Global, LLC. |
| Company location | Austell, GA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3020 |
More recalls from ASP Global, LLC. · all medical device recalls · recalls from August 2026