Z-0935-2018Class II

Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It...

Name: Z-0935-2018 Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It...
Creator: Becton Dickinson & Co.
Published: 2017-10-03
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-10-03 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Co. began a recall of Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutritional... on 2017-10-03. FDA classified it as Class II and gives the reason as "HighPuragar was mislabeled and inadvertently sold as Noble Agar". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0935-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-03
Posted: 2018-03-09
Terminated: 2018-10-09
Recalling firm: Becton Dickinson & Co
Product: Difco" Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities. It is used in electrophoretic and nutritional procedures and in preparing microbiological culture media when increased purity is required.
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: HighPuragar was mislabeled and inadvertently sold as Noble Agar.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: On October 3, 2017 an URGENT MEDICAL DEVICE PRODUCT RECA:LL letter was mailed to customers informing them of the recall and requesting that their inventory be checked for product, which should be quarantined and then thrown away. Also, to share notification of recall to any other customers that may have received product. Firm will replace any discarded inventory. Questions or concerns can be directed to: 1-800-638-8663.
Quantity in commerce: 216 bottles
Distribution: USA (nationwide) Distribution to the states of and including Puerto Rico : AL, AZ, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA,TN, TX, UT, VA, WA
Product codes and lots: catalog number 214230, lot 7109502

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0935-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0935-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09

Product code JSO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)