Mermaid Medical M-Biopsy Coaxial Introducer Needle — Class II medical device recall Z-2190-2015
Terminated recall by Mermaid Medical A/S, reported 2015-07-29, distributed in FL, PR. Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential fo
| Recall number | Z-2190-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mermaid Medical A/S, Stenl?se, N/A, Denmark |
| Recall initiated | 2015-06-15 |
| Classified | 2015-07-22 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2015-12-07 |
| Distributed | FL, PR |
| Quantity | 320 |
| Reason classes | foreign material |
| Lot numbers | P000148, P000230, P000290, P000291, P000299, P000360 |
| Model numbers | N20314010, N20320020, N20414010, N20420020 |
Product
Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.
Reason for recall
Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer of the cannula.
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-2190-2015. 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.