RecallRadar

FDA Device recall Z-2547-2016

Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intend…

On 2016-08-24 the FDA classified a Class II recall of Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intend… by Bard Peripheral Vascular, citing may contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2547-2016
ClassificationClass II
Statusterminated
Initiated2016-07-06
Published2016-08-24
Last updated2026-09-13 11:54 UTC
CompanyBard Peripheral Vascular
DistributionUS

Product

Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

Reason

May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.

Identifiers

code_infoLot Number: REZK0479

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2547-2016%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.