Ultrasound USB needles — Class II medical device recall Z-1609-2014
Terminated recall by RM Temena GmbH, reported 2014-05-21, distributed in IL, MD. Ultrasound needles may be defective and leak at the needle hub.
| Recall number | Z-1609-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RM Temena GmbH, Felsberg, Germany |
| Recall initiated | 2014-03-19 |
| Classified | 2014-05-12 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2016-09-19 |
| Distributed | IL, MD |
| Quantity | 7,370 needles |
| Reason classes | packaging |
| Lot numbers | B3070012, B3250001, B3250026 |
| Model numbers | USB050-22 |
| Expiration dates | 2018-02-28, 2018-06-30 |
Product
Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
Reason for recall
Ultrasound needles may be defective and leak at the needle hub.
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-1609-2014. 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.