FDA Medical Device Recalls (openFDA)
Beaver Visitec: Safety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
- Recall number
- Z-2342-2018
- Recalling firm
- Beaver Visitec
- Product
- Safety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
- Status
- Terminated
- Initiated
- 2018-05-14
- Posted
- not on file
- Terminated
- 2021-06-08
- Reason
- Blades are loose in handles and may fall out due to non cured epoxy
- Root cause
- Nonconforming Material/Component
- Action
- On May 14, 2018, Beaver-Visitec International (BVI) issued PRODUCT RECALL NOTICES to customers. Customers were advised to take the following actions: -Inspect stock, quarantine and destroy product per internal procedures. -Complete and return the response form via email to claimsus@bvimedical.com - Provide objective evidence of product destruction with BVI so that credit to customer accounts can be applied. Customers with questions may contact the firm by calling 866-906-8080.
- Quantity
- 1354 units
- Distribution
- US Nationwide in the states of CA, IA, CO, HI, IA, MD & TX
- Lot, serial or model codes
- Lot Numbers: 6002436 & 6002663
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EMF
- 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