RegWardenFDA facility compliance records
Recall

Class II — Beaver Visitec

Recalling firmBeaver-Visitec International, Inc.
Registered facilityBeaver-Visitec International, Inc (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonMislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device
ProductBeaver 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
Quantity196 boxes (10units/box)
DistributionWorldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS
Initiated2019-03-12
Classified2019-04-09
Terminated2020-08-11
Recall numberZ-1111-2019
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Beaver Visitec (Z-1111-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82382/

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