Exact FDA event identifier

Event 94150

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

Open FDA event record

Event summary

Timeline bucket: January 05, 2024
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Olympus Corporation of the Americas

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

Hemostasis Probe, Model: CD-B622LA

Z-1481-2024

Recall number: Z-1481-2024
Initiated: January 05, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Olympus Corporation of the Americas
Quantity: 36 units (all OUS)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

mispackaged

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.

Code information

Model Number: CD-B622LA; UDI/DI: 00821925039452; Lot Number: KR214212

Distribution pattern

International distribution only.