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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 99132

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 03, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Remel, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2623-2026
Recall number
Z-2623-2026
Initiated
June 03, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Remel, Inc
Quantity
1573

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reduced or no recovery of some strains of Neisseria gonorrhoeae.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Code information

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 pattern

Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.