# Class II recall Z-0012-2027: ASP Global, LLC.

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0012-2027 |
| Recalling firm | ASP Global, LLC. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Brand Name: Expressaire  Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 10) WHITE  Model/Catalog Number: 564010  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. |
| Quantity | 6100 |
| 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. |
| Recall initiated | 2026-08-24 |
| Reported | 2026-10-07 |
| Firm location | Austell, GA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 29 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0012-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.