Data Foundry

Medical device recalls 2016

Bard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part… — Class II medical device recall Z-2547-2016

Terminated recall by Bard Peripheral Vascular Inc, reported 2016-08-24, distributed nationwide. May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.

Recall numberZ-2547-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBard Peripheral Vascular Inc, Tempe, AZ, United States
Recall initiated2016-07-06
Classified2016-08-16
Reported by FDA2016-08-24
Terminated2016-11-17
DistributedNationwide (US)
Countries outside the USAR, AU, BE, CA, CN, TW
Quantity1,250 units
Lot numbersREZK0479
Model numbersC1816B

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 for recall

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

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-2547-2016. 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.