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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97224

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

Open FDA event record

Event summary

Timeline bucket
July 11, 2025
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

4 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 4

Blood Agar,5% Sheep Blood 100/PK, Product Number R01202

Z-2223-2025
Recall number
Z-2223-2025
Initiated
July 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Remel, Inc
Quantity
1552 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
contamination of Listeria monocytogenes

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

The products may contain surface and subsurface contamination of Listeria monocytogenes.

Code information

UDI-DI: 848838000645; Lot Numbers: 271595, 271596

Distribution pattern

US Nationwide distribution.

device · product 2 of 4

Strep Selective II Agar, Product Number R01859

Z-2224-2025
Recall number
Z-2224-2025
Initiated
July 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Remel, Inc
Quantity
371 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
contamination of Listeria monocytogenes

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

The products may contain surface and subsurface contamination of Listeria monocytogenes.

Code information

UDI-DI: 848838003158; Lot Numbers: 271613

Distribution pattern

US Nationwide distribution.

device · product 3 of 4

Blood/EMB, Levine 100/PK, Product Number R02041

Z-2225-2025
Recall number
Z-2225-2025
Initiated
July 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Remel, Inc
Quantity
750 units

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
contamination of Listeria monocytogenes

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

The products may contain surface and subsurface contamination of Listeria monocytogenes.

Code information

UDI-DI: 848838003684; Lot Numbers: 274194

Distribution pattern

US Nationwide distribution.

device · product 4 of 4

Blood/MacConkey Biplate 100/PK, Product Number R02049

Z-2226-2025
Recall number
Z-2226-2025
Initiated
July 11, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Remel, Inc
Quantity
611 untis

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
contamination of Listeria monocytogenes

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

The products may contain surface and subsurface contamination of Listeria monocytogenes.

Code information

UDI-DI: 848838003684; Lot Numbers: 274194

Distribution pattern

US Nationwide distribution.