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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97477

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

Open FDA event record

Event summary

Timeline bucket
August 26, 2025
Product types
Drug
Classifications
Class II
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

STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.

D-0652-2025
Recall number
D-0652-2025
Initiated
August 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B BRAUN MEDICAL INC
Quantity
26,316 3000 mL bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

Code information

Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027

Distribution pattern

U.S. Nationwide

drug · product 2 of 2

0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.

D-0653-2025
Recall number
D-0653-2025
Initiated
August 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
B BRAUN MEDICAL INC
Quantity
16,228 3000 mL bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.

Code information

Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.

Distribution pattern

U.S. Nationwide