Exact FDA event identifier

Event 95607

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

Open FDA event record

Event summary

Timeline bucket: October 21, 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

Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

Z-0363-2025

Recall number: Z-0363-2025
Initiated: October 21, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Karl Storz Endoscopy
Quantity: 40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.

Code information

Product/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222

Distribution pattern

U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.