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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98079

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 02, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Microbiologics 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

3 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 3

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P

Z-0984-2026
Recall number
Z-0984-2026
Initiated
December 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Microbiologics Inc
Quantity
86 units (127 additional units 12/22/25)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

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

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Code information

UDI-DI: 20845357006459; Lot Numbers: 325-120-3, 325-120-7, Additional Lots added 12/22/25: 325-119-1, 325-119-5

Distribution pattern

Worldwide - US Nationwide.

device · product 2 of 3

KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K

Z-0985-2026
Recall number
Z-0985-2026
Initiated
December 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Microbiologics Inc
Quantity
18 units (9 additional units 12/22/25)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

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

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Code information

UDI-DI: 30845357006463; Lot Numbers: 325-120-1, 325-120-4, 325-120-6, Additional Lots added 12/22/25: 325-119-2

Distribution pattern

Worldwide - US Nationwide.

device · product 3 of 3

LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L

Z-0986-2026
Recall number
Z-0986-2026
Initiated
December 02, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Microbiologics Inc
Quantity
1 unit (16 additional units added 12/22/25)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

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

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Code information

UDI-DI: 10845357006476; Lot Numbers: 325-120-5, Additional lots added 12/22/25: 325-119-3, 325-119-6

Distribution pattern

Worldwide - US Nationwide.