Data Foundry

Medical device recalls 2015

Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood… — Class II medical device recall Z-0976-2015

Terminated recall by Becton Dickinson & Co., reported 2015-01-21, distributed nationwide. A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepare

Recall numberZ-0976-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBecton Dickinson & Co., Sparks, MD, United States
Recall initiated2014-06-06
Classified2015-01-14
Reported by FDA2015-01-21
Terminated2016-08-12
DistributedNationwide (US)
Countries outside the USBE, CA, PH, SG, TW
Quantity775 cases
Reason classesmicrobial contamination, sterility
Pathogenslisteria monocytogenes
Lot numbers4099228
Model numbers221263

Product

Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the growth and recovery of fastidious microbial species.

Reason for recall

A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present.

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-0976-2015. 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.