RecallRadar

FDA Device recall Z-1609-2014

Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22

On 2014-05-21 the FDA classified a Class II recall of Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22 by Rm Temena, citing ultrasound needles may be defective and leak at the needle hub.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1609-2014
ClassificationClass II
Statusterminated
Initiated2014-03-19
Published2014-05-21
Last updated2026-09-13 11:53 UTC
CompanyRm Temena
DistributionIL, MD

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

Ultrasound needles may be defective and leak at the needle hub.

Identifiers

code_infoLot B3070012 EXP 2018-02-28 Lot B3250001 EXP 2018-06-30 Lot B3250026 EXP 2018-06-30

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1609-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.