Exact FDA event identifier

Event 80311

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

Open FDA event record

Event summary

Timeline bucket: May 14, 2018
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

Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery

Z-2342-2018

Recall number: Z-2342-2018
Initiated: May 14, 2018
Classification: Class II
Status: Terminated
Recalling firm: Beaver Visitec
Quantity: 1354 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Blades are loose in handles and may fall out due to non cured epoxy

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blades are loose in handles and may fall out due to non cured epoxy

Code information

Lot Numbers: 6002436 & 6002663

Distribution pattern

US Nationwide in the states of CA, IA, CO, HI, IA, MD & TX