Data Foundry

Medical device recalls 2021

Catalog # BEK4511 — Class II medical device recall Z-0153-2022

Terminated recall by Bard Peripheral Vascular Inc, reported 2021-10-27, distributed in CA, GA, HI, IL, IN, LA, MO, MS…. Due to misbranded products shipped to customers.

Recall numberZ-0153-2022
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBard Peripheral Vascular Inc, Tempe, AZ, United States
Recall initiated2021-08-24
Classified2021-10-19
Reported by FDA2021-10-27
Terminated2024-12-23
DistributedCA, GA, HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, WA
Quantity360 devices
Reason classeslabeling
UPC / GTIN / UDI-DI50885403057265
Serial numbers0001379055
Model numbersBEK4511

Product

Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy technique

Reason for recall

Due to misbranded products shipped to customers.

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-0153-2022. 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.