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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95954

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

Open FDA event record

Event summary

Timeline bucket
December 19, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Karl Storz Endoscopy

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

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.

device · product 1 of 1

Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE

Z-0837-2025
Recall number
Z-0837-2025
Initiated
December 19, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Karl Storz Endoscopy
Quantity
285 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Reprocessing Controls

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.

Code information

Lot Numbers: All lots of the affected material number/Primary DI Number: 04048551194416

Distribution pattern

US: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OR, PA, SC, TX, VA OUS: None