FDA Medical Device Recalls (openFDA)
Beaver Visitec International, Inc.: 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
- Recall number
- Z-0228-2022
- Recalling firm
- Beaver Visitec International, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2021-10-08
- Posted
- not on file
- Terminated
- not on file
- Reason
- Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
- Root cause
- Under Investigation by firm
- Action
- BVI notified Consignees by Urgent Medical Device Recall letter on 10/8/21 via registered mail. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from these lots that are subject to recall. If you have further distributed this product, please notify your customers by initiating a subrecall. Consider all potential users of this product in your user supply chain. You are encouraged to a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Reply Form (BRF) and indicate whether you have affected product to return. 3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. Return the completed BRF to BVI by one of these methods: " Fax to 866-552-4919 " Email the attached to beavervisitec3997@sedgwick.com 5. Return your product to STERICYCLE using the enclosed UPS pre-paid return label: Stericycle 2670 Executive Drive, Suite A Indianapolis, IN 46241 Attn: Event 3997 If you received this notification without the prepaid UPS label and Business Reply Form (BRF), and require additional shipping labels, or if you have questions regarding the return procedure, please contact Stericycle Inc. at 866-606-8264 (Mon.-Fri. 8:00 am - 5:00 pm Eastern Time). Please direct any questions regarding this matter to our customer service department by email ClaimsUS@bvimedical.com and please include in the subject line: Master Case PIR 263383
- Quantity
- 500 eaches
- Distribution
- Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK
- Lot, serial or model codes
- Lot Numbers 3296729, 3299124, 3305081, 3307565, 3312464, 3324620, 6033588. UDI: " Primary: 00886158112839 " Secondary: 30886158112830 " Tertiary: 50886158112834
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJK
- Firm FEI
- 1211998
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28