Tourni-Cot — Class II medical device recall Z-0945-2021
Terminated recall by Mar-Med Co, reported 2021-02-10, distributed nationwide. A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it
| Recall number | Z-0945-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mar-Med Co, Grand Rapids, MI, United States |
| Recall initiated | 2020-12-28 |
| Classified | 2021-02-02 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2023-09-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, DE, ES, FR, GB, GR, IT, JP, NL, SE, SG |
| Quantity | 52,000 |
| UPC / GTIN / UDI-DI | 00855364004085 |
Product
Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.
Reason for recall
A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. The device may tear into two pieces with a portion remaining in place, which can continue to constrict the vessels. This type of failure can result in digit ischemia.
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-0945-2021. 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.