Official recall notice

FDA DeviceClass IINotable

Disposable Tourniquet Cuff Recall (Oct 2026) – ASP Global

Product: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-LINE (CS 10) GREEN Model/Catalog Number: 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 operative field. Component: No

Recall date
2026-10-07
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.

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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: 564015 UDI-DI: (01) 00885914044650 All Lots produced from 01SEP2016 to 01MAR2023: S0823STY, S0922STY, S1101STY, R1101STY, Q0301STY, Q1115STY, P0620STY, O0815STY, O1020STY, N0730STY, M0130STY, M0730STY, M0930STY, M1230STY

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