CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report
GC Agar Base R04030 recalled by Remel
Remel is recalling GC Agar Base R04030, distributed nationwide in the US. The recall was initiated on 3 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2623-2026
- FDA event ID
- 99132
- Recalling firm
- Remel, Lenexa, KS
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jun 2026
- FDA classified
- 30 Jun 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Jun 2026 | Recall initiated by company | |
| 30 Jun 2026 | Classified by FDA | +27 days |
| 8 Jul 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Product as listed by the FDA
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
Questions about this recall
Why was it recalled?
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Which lots are 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
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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