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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97841

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

Open FDA event record

Event summary

Timeline bucket
October 27, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Otsuka ICU Medical LLC

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

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.

drug · product 1 of 1

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

D-0143-2026
Recall number
D-0143-2026
Initiated
October 27, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Otsuka ICU Medical LLC
Quantity
509,360 100 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 flexible container leaks.

Code information

Lot # 1029921, Exp Date: 28 February 2027

Distribution pattern

Distributed Nationwide in the USA.