Z-0975-2015Class II

CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium...

Name: Z-0975-2015 CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium...
Creator: Becton Dickinson & Co.
Published: 2014-06-06
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2014-06-06 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium particularly useful or the isolation and... on 2014-06-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0975-2015
Classification: Class II
Status: Terminated
Initiated: 2014-06-06
Posted: 2015-01-14
Terminated: 2016-08-12
Recalling firm: Becton Dickinson & Co
Product: CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium particularly useful or the isolation and cultivation of obligate anaerobes from clinical specimens. It supports the growth of a wide variety of obligately anaerobic, faculatively anaerobic, microaerophilic and aerobic bacteria.
Product code: JSG Culture Media, Non-Selective And Non-Differential
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: BD Diagnostic Systems sent a Field Correction Notice dated August 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue to follow all surveillance requirements of their laboratory upon confirmation of Listeria monocytogenes. Laboratory staff should notify their respective state health department. Customers with questions should contact BD Technical Services at 800-638-8663. For questions regarding this recall call 410-316-4000.
Quantity in commerce: 1,530 cases (100 plates/case)
Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan.
Product codes and lots: Catalogue # 221734 with Lot #4077423

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0975-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0974-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-14
Z-0975-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-14
Z-0976-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-14

Product code JSG

K803025Class ICdc Anaerobe Blood AgarBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1980-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)