Beaver Xstar Crescent Knife Surgical Blades Recalled for Wrong Blade Orientation
Beaver Visitec International recalls CustomEyes Cataract Surgical Kits containing Xstar Crescent Knives with incorrect blade orientation. Kits labeled as 55-degree bevel-down blades actually contain bevel-up blades.
What this means for you
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 medical device recall with risk of patient harm from surgical blade orientation mismatch. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Beaver Visitec International is recalling 500 units of CustomEyes Cataract Surgical Kits containing Beaver Xstar Crescent Knives (2.5mm). The kits are labeled and packaged as containing 55-degree bevel-down blades, but actually contain bevel-up blades instead. This mismatch between label and product could result in incorrect surgical technique and potential patient harm if used without verification.
The recall affects surgical kits distributed nationwide and internationally to Australia, Austria, France, Germany, Netherlands, Spain, Japan, Russia, South Africa, and the United Kingdom. The affected lot numbers are 3296729, 3299124, 3305081, 3307565, 3312464, 3324620, and 6033588.
Healthcare facilities should stop use of affected kits and verify the actual blade orientation before any surgical application. Contact Beaver Visitec International for information regarding product replacement, refunds, or guidance on safe use.
The recalled product
- Product
- bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- blade-orientation-mismatch
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot Numbers 3296729
- 3299124
- 3305081
- 3307565
- 3312464
- 3324620
Distribution
Distributed nationwide across the United States.
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