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FDAClass II · Medical device · Recalled July 8, 2026
GC Agar Base (150mm) 10/PK R04030 recall — Remel, Inc
Hazard: Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2623-2026
- Brand
- Remel
- Classification
- Class II
- Units affected
- 1,573
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Affected products
Companies & origin
- Recalling firm location
- Lenexa, KS, United States
- Firm address
- 12076 Santa Fe Trail Dr, N/A, 66215-3519
Identifying details (verbatim from the notice)
- Product codes / 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
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
- Firm notified the public via
- Letter
- FDA event ID
- 99132
- Recall initiated
- June 3, 2026
- FDA classified
- June 30, 2026
- FDA report date
- July 8, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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