T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can — Class II medical device recall Z-2189-2015
Terminated recall by Argon Medical Devices, Inc, reported 2015-07-29. Potential defect in the forming of the primary package of the blister that may compromise the sterility of the
| Recall number | Z-2189-2015 |
|---|---|
| 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 | 2015-06-18 |
| Classified | 2015-07-21 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2016-06-23 |
| Quantity | 10,290 units |
| Reason classes | sterility |
| Lot numbers | 11088295, 11088596, 11088597, 11089105, 11089366, 11094182, 11094681, 11094912, 11095381, 11095844, 11095845, 11095951, 11096558, 11097278, 11097504, 11098024, 11098647, 11099173 |
| Model numbers | DBMNJ0804TL, DBMNJ1104TL, DBMNJ1304 |
Product
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304
Reason for recall
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-2189-2015. 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.