MATResponder Tourniquet — Class II medical device recall Z-0228-2016
Terminated recall by Pyng Medical Corporation, reported 2015-11-11. Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging
| Recall number | Z-0228-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pyng Medical Corporation, Richmond, N/A, Canada |
| Recall initiated | 2015-08-31 |
| Classified | 2015-11-05 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-07-05 |
| Countries outside the US | AU, CA, CO, DE, ES, FI, FR, GB, HU, ID, IL, IT, JP, MX, NL, PL |
| Quantity | 6,728 |
| Lot numbers | SL115802, SL12131 |
| Expiration dates | 2023-10, 2024-01, 2024-07, 2024-08, 2024-12 |
Product
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs
Reason for recall
Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Each tourniquet was tested for functionality, but in some cases, the tourniquet was not returned to its Ready position prior to packaging.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0228-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.