The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0229-2022·Announced 2021-11-24

Beaver Xstar Crescent Knife surgical blades recalled for specification mismatch

Beaver Visitec is recalling CustomEyes surgical kits where Crescent Knives contain bevel-up blades instead of the specified bevel-down blades. The specification error could affect surgical precision during cataract procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of surgical instruments with a specification mismatch that could compromise surgical precision. No illnesses or injuries have been reported; the defect represents a risk-of-harm product where injury has not yet been reported, per the severity rubric.

Plain-English summary

Beaver Visitec International, Inc. is recalling CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife components with a blade specification error. The affected kits are packaged and labeled as containing 2.5mm Crescent Knives with 55-degree bevel-down blades, but instead contain bevel-up blades.

This specification mismatch could affect the precision and safety of cataract surgical procedures, as surgeons select instruments based on blade specifications. The recall affects 125 units distributed nationwide and internationally to Australia, Austria, France, Germany, the Netherlands, Spain, Japan, Russia, South Africa, and the United Kingdom.

The recall involves Lot Numbers 6032947 and 6033588, identified by UDI codes. Medical facilities should immediately quarantine and review their CustomEyes Kits matching these lot numbers and discontinue use until properly corrected units are obtained. Contact Beaver Visitec International, Inc. for instructions on return or replacement of the affected kits.

The recalled product

Product
bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
125

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Beaver Visitec International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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