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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97433

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

Open FDA event record

Event summary

Timeline bucket
August 18, 2025
Product types
Drug
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
B BRAUN MEDICAL INC

Dossier provenance

Source snapshots represented here

  • openFDA Drug 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.

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

2 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.

drug · product 1 of 2

Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07

D-0627-2025
Recall number
D-0627-2025
Initiated
August 18, 2025
Classification
Class I
Status
Ongoing
Recalling firm
B BRAUN MEDICAL INC
Quantity
46,032 containers

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter

Code information

Lot #: J4S807, Exp 5/31/2027

Distribution pattern

U.S.A. Nationwide

drug · product 2 of 2

0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09

D-0628-2025
Recall number
D-0628-2025
Initiated
August 18, 2025
Classification
Class I
Status
Ongoing
Recalling firm
B BRAUN MEDICAL INC
Quantity
47,148 containers

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter.

Code information

Lot #: V3K770, Exp 1/31/2026

Distribution pattern

U.S.A. Nationwide