Recall Ledger

GC Agar Base recall (Remel, Inc)

Medical deviceClass IIOngoing

Summary: Remel, Inc is recalling GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460. Reason: Reduced or no recovery of some strains of Neisseria gonorrhoeae.

What is being recalled

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

Why

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2623-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJune 3, 2026
ReportedJuly 8, 2026
CompanyRemel, Inc
Company locationLenexa, KS, United States
Initiated byVoluntary: Firm initiated
Quantity1573

More recalls from Remel, Inc · all medical device recalls · recalls from June 2026

Official FDA record