FDA Device recall Z-0014-2027
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 10) BLUE Model/Catalog Number: 564012 Software Versio…
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 10) BLUE Model/Catalog Number: 564012 Software Versio… by Asp Global, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0014-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-24 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Asp Global |
| Distribution | US |
Product
Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-LINE (CS 10) BLUE Model/Catalog Number: 564012 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.
Identifiers
| code_info | Lot Code: Model Number: 564012 UDI-DI: (01) 00885914044629 All Lots produced from 01SEP2016 to 01MAR2023: S0922STY…Lot Code: Model Number: 564012 UDI-DI: (01) 00885914044629 All Lots produced from 01SEP2016 to 01MAR2023: S0922STY, S1101STY, R0601STY, R1101STY, Q0301STY, Q1115STY, P0325STY, P0620STY, P1015STY, O1020STY, N0730STY, M0130STY, M0430STY, M0730STY, M0930STY, M1230STY |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Asp Global
- Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 12) GRAY Model/Catalog Number: A70107005 Software Vers…
FDA Device · Class II · 2026-10-07 · Asp Global - Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 1 LINE (10) Model/Catalog Number: DB-7018-01Q Software Version: N…
FDA Device · Class II · 2026-10-07 · Asp Global - Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Versi…
FDA Device · Class II · 2026-10-07 · Asp Global - Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER, 2-LINE (CS 12) ORANGE Model/Catalog Number: A7010…
FDA Device · Class II · 2026-10-07 · Asp Global - Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-Line, White Model/Catalog Number: ASP-564011 Software Version: N…
FDA Device · Class II · 2026-10-07 · Asp Global
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0014-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.