10 ga ARS Decompression Needle — Class II medical device recall Z-2520-2021
Terminated recall by North American Rescue LLC., reported 2021-09-29, distributed in PR. The device includes the incorrect Instructions for Use.
| Recall number | Z-2520-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | North American Rescue LLC., Greer, SC, United States |
| Recall initiated | 2021-08-27 |
| Classified | 2021-09-23 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2024-01-19 |
| Distributed | PR |
| Countries outside the US | AU, CH, CZ, DE, DK, FR, IE, IT, PL |
| Quantity | 51,424 units |
| Lot numbers | W668NI, W693WF, W694ZH, W695DD, W696FN, W697IJ |
| Model numbers | ZZ-0298 |
Product
10 ga ARS Decompression Needle, Part Number ZZ-0298
Reason for recall
The device includes the incorrect Instructions for Use.
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-2520-2021. 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.