FDA Medical devices recall ·
GC Agar Base (150mm) 10/PK R04030 recall
- Recall number
- Z-2623-2026
- Date
- (initiated June 3, 2026)
- Company / brand
- Remel, Inc
12076 Santa Fe Trail Dr, Lenexa, KS, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1573
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Why was it recalled?
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2623-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.