Class II recall Z-0018-2027: ASP Global, LLC.
Class II recall Z-0018-2027: ASP Global, LLC. (Georgia): ASP Global, LLC. Dated 29 days ago, it is in the active follow-up window. Score 62/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 68 related GA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0018-2027 |
| 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, 20" X 6" 1-LINE (CS 10) NAVY BLUE Model/Catalog Number: 564017 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 | 1220 |
| 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 |
| Peer records CSV (69 GA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-07
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Class II recall Z-0018-2027: ASP Global, LLC. and 69 Georgia peers
- Georgia FDAPulse records like this one: 69
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Georgia peer: $13,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
62 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 29 days ago.
What is the FDAPulse record for Class II recall Z-0018-2027: ASP Global, LLC. in Georgia?
Class II device recall Z-0018-2027 by ASP Global, LLC.: Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled wit
How does Class II recall Z-0018-2027: ASP Global, LLC. compare to other Georgia FDAPulse records?
It is 29 days old, still within a typical 45-day follow-up window.
Class II recall Z-0018-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0018-2027 | GA | 2026-10-07 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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