Z-2224-2025Class II

Strep Selective II Agar, Product Number R01859

Name: Z-2224-2025 Strep Selective II Agar, Product Number R01859
Creator: Remel, Inc
Published: 2025-07-11
License: https://open.fda.gov/license/

Remel Inc / initiated 2025-07-11 / Open, Classified

FDA source

Remel, Inc began a recall of Strep Selective II Agar, Product Number R01859 on 2025-07-11. FDA classified it as Class II and gives the reason as "The products may contain surface and subsurface contamination of Listeria monocytogenes". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2224-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-11
Posted: 2025-07-31
Recalling firm: Remel Inc
Product: Strep Selective II Agar, Product Number R01859
Product code: JSI Culture Media, Selective And Differential
Reason for recall: The products may contain surface and subsurface contamination of Listeria monocytogenes.
FDA root cause: Under Investigation by firm
Action: An Urgent: Medical Device Recall notification letter dated 7/11/25 was sent to customers. ACTIONS TO BE TAKEN BY THE CUSTOMER: Our records indicate that you have received above products. Accordingly, in keeping with our Quality Policy, we request that you please notify any personnel who need to be aware of the potential for visible contamination of products listed above and destroy any remaining inventory of lots listed above and complete the accompanying Acknowledgement form. Return the completed form indicating number of units destroyed via email to [email protected] in order for your replacement/credit to be processed. Complete and return the response form even if you no longer have the affected product on hand. Please keep this notification on file. This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email [email protected]. TYPE OF ACTION BY THE MANUFACTURER: Remel Inc., part of Thermo Fisher Scientific, is investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.
Quantity in commerce: 371 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 848838003158; Lot Numbers: 271613

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2224-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2223-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31
Z-2224-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31
Z-2225-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31
Z-2226-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-31

Product code JSI

K843193Class IStrep Selective IIRemel Co. / cleared 1984-09-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)