Data Foundry

Medical device recalls 2026

GC Agar Base — Class II medical device recall Z-2623-2026

Ongoing recall by Remel, Inc, reported 2026-07-08, distributed nationwide. Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Recall numberZ-2623-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmRemel, Inc, Lenexa, KS, United States
Recall initiated2026-06-03
Classified2026-06-30
Reported by FDA2026-07-08
DistributedNationwide (US)
Countries outside the USCA, GB, SG
Quantity1,573
UPC / GTIN / UDI-DI00848838001796, 00848838004469
Lot numbers336864, 338950, 345992, 348754, 356898, 359912, 359925, 365679, 367829, 371863, 374235, 376786, 376799, 381488, 382136, 384712, 385224, 391312, 393478, 393488, 396333, 402458, R04030GC

Product

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

Reason for recall

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2623-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.