Exact FDA event identifier

Event 95582

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

Open FDA event record

Event summary

Timeline bucket: October 14, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Cook Incorporated

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

Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789

Z-0499-2025

Recall number: Z-0499-2025
Initiated: October 14, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Cook Incorporated
Quantity: 10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Devices from the affected device lots have labels that state the incorrect expiration dates.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices from the affected device lots have labels that state the incorrect expiration dates.

Code information

UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020

Distribution pattern

International Distribution to: Korea only