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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91235

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

Open FDA event record

Event summary

Timeline bucket
November 30, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Beaver Visitec International, Inc.

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 EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630

Z-0782-2023
Recall number
Z-0782-2023
Initiated
November 30, 2022
Classification
Class II
Status
Ongoing
Quantity
599 units (US): 410 units; 189 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier has been compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection

Code information

UDI: 00886158100010 Lot Number: 3391035 Additionally Packaged as a component of the READYPAK KIT Cat: 584896 Lots: 6054175, 6053035

Distribution pattern

US Nationwide distribution.