BONE MARROW ASPIRATION NEEDLE 15G x 2 — Class II medical device recall Z-1194-2017
Terminated recall by Argon Medical Devices, Inc, reported 2017-02-22, distributed nationwide. The recalling firm received a complaint from one of their customers of a potential defect in the forming of th
| Recall number | Z-1194-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argon Medical Devices, Inc, Athens, TX, United States |
| Recall initiated | 2017-01-18 |
| Classified | 2017-02-13 |
| Reported by FDA | 2017-02-22 |
| Terminated | 2017-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CO, EC, JP, NZ |
| Quantity | 497 boxes |
| Reason classes | sterility |
| Lot numbers | 11156986, 11158618, 11158620 |
Product
BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens
Reason for recall
The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
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-1194-2017. 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.