Exact FDA event identifier

Event 82382

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

Open FDA event record

Event summary

Timeline bucket: March 12, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Beaver Visitec

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

Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures

Z-1111-2019

Recall number: Z-1111-2019
Initiated: March 12, 2019
Classification: Class II
Status: Terminated
Recalling firm: Beaver Visitec
Quantity: 196 boxes (10units/box)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device

Code information

Lot Number: 6008554

Distribution pattern

Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS