Z-2162-2024 Class II Ongoing
FDA device recall Z-2162-2024 was initiated by Beaver Visitec International, Inc. on May 10, 2024 and is designated Class II. Reason for recall: The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down). The recall status is ongoing. Affected quantity: 126 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 26, 2024
- Initiation Date
- May 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 126 units
Product Description
Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
Reason for Recall
The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, UK, and Italy.
Code Information
Xstar Safety Slit Knife: UDI-DI: 00886158001652; Lot Number: 6058854; CustomEye Kit # 584562 , lot # 6068524; CustomEye Kit # 584562 , lot # 6068025; CustomEye Kit # 5800109, lot # 6068285
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2162-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026