Z-2623-2026Class II

GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460

Name: Z-2623-2026 GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Creator: Remel, Inc
Published: 2026-06-03
License: https://open.fda.gov/license/

Remel Inc / initiated 2026-06-03 / Open, Classified

FDA source

Remel, Inc began a recall of GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460 on 2026-06-03. FDA classified it as Class II and gives the reason as "Reduced or no recovery of some strains of Neisseria gonorrhoeae". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2623-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-03
Posted: 2026-06-30
Recalling firm: Remel Inc
Product: GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Product code: JTY Culture Media, For Isolation Of Pathogenic Neisseria
Reason for recall: Reduced or no recovery of some strains of Neisseria gonorrhoeae.
FDA root cause: Under Investigation by firm
Action: On June 3, 2026, the firm began notifying customers via letters titled Urgent Medical Device Recall. Customers were instructed to destroy any remaining inventory of affected lots and inform the recalling firm of the amount destroyed to receive a replacement or credit. In addition, customers should notify necessary personnel. Users should review previously reported results generated using the affected lots and assess whether retesting is appropriate based on laboratory procedures.
Quantity in commerce: 1573
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
Product codes and lots: R01460 - GC Agar Base (100mm) 10/PK UDI-DI 848838001796 Lots 338950 356898 359912 365679 371863 376799 382136 384712 393488 396333 402458; R04030 - GC Agar Base (150mm) 10/PK UDI-DI 848838004469 Lots 336864 345992 348754 359925 367829 374235 376786 381488 385224 391312 393478

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2623-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2623-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-30

Product code JTY

K954986Class IIGc Base W/ 1% GchiRemel, L.P. / cleared 1996-02-16

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)