GC Agar Base (150mm) 10/PK R04030 recallZ-2623-2026 · Remel, Inc · initiated Jun 3, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remel, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2623-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 3, 2026
- Posted by the FDA
- Jun 30, 2026
- Recalling firm
- Remel, Inc
- Quantity
- 1573
- Product code
- JTY
- FDA submissions
- K954986
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
Product description
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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