TrypticaseTM Soy Agar with 5% Sheep Blood — Class II medical device recall Z-0974-2015
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 number | Z-0974-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2014-06-06 |
| Classified | 2015-01-14 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2016-08-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, PH, SG, TW |
| Reason classes | microbial contamination, sterility |
| Pathogens | listeria monocytogenes |
| Lot numbers | 4022158, 4050354, 4086399, 4086443, 4092199, 4099206, 4143653 |
| Model numbers | 221261, 221291 |
Product
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
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
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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.