Official recall notice
Disposable Tourniquet Cuff Recall (Oct 2026) – ASP Global
Product: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 10) BLUE Model/Catalog Number: 564013 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
- Recall date
- 2026-10-07
- Brand
- ASP Global, LLC.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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.
Affected products
Lot Code: Model Number: 564013 UDI-DI: (01) 00885914044636 All Lots produced from 01SEP2016 to 01MAR2023: S0823STY, S0922STY, S1101STY, R0801STY, R1101STY, Q0301STY, Q0930STY, P0325STY, P0620STY, O0815STY, N0330STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY