FDA Medical Device Recalls (openFDA)
Beaver Visitec International, Inc.: Xstar Kojo Safety Slit Knife, 2.5mm 45 Bevel Up, Part Number 373025
- Recall number
- Z-0633-2024
- Recalling firm
- Beaver Visitec International, Inc.
- Product
- Xstar Kojo Safety Slit Knife, 2.5mm 45 Bevel Up, Part Number 373025
- Status
- Open, Classified
- Initiated
- 2023-10-10
- Posted
- 2024-01-04
- Terminated
- not on file
- Reason
- One lot of Part Number 373025, Xstar Kojo Safety Slit Knife 2.5mm 45 bevel up, incorrectly contains a bevel down blade instead of a bevel up blade.
- Root cause
- Under Investigation by firm
- Action
- An "URGENT Field Safety Notice" dated 10/10/23 was sent to customers. Actions Required by You Our records show you received one or more affected product. You can recognize the affected product by determining whether the lot number printed on the device label is one of the affected lots. PLEASE perform the following actions: 1. Immediately examine your inventory and determine if the blades on the knives are bevel-up as intended or bevel down. Only destroy the knives in your inventory that have the incorrect bevel orientation (bevel down). If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged to use a copy of this recall notification letter when contacting your customers. 2. Review the enclosed Business Reply Form (BRF) and indicate whether you have the affected product in your possession. 3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) destroyed. 4. Return the completed BRF and evidence of destruction of affected product to BVI by emailing the attached to Recall@bvimedical.com. BVI values your business and apologizes for the inconvenience this may have caused. Please direct any questions regarding credit to our customer service department by email and include in the subject line: Master Case PIR 00487979. Country Customer Service Email UK UKCustomerSupport@bvimedical.com FR serviceclient@bvimedical.com DE/ AT Kundendienst@bvimedical.com IT servizioclienti@bvimedical.com ROW ROWCustomerSupport@bvimedical.com
- Quantity
- 2160 units
- Distribution
- International Distribution to Japan.
- Lot, serial or model codes
- UDI-DI: 30886158000373; Lot Number: 6049877
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HNN
- 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