FDA Medical Device Recalls (openFDA)
Beaver Visitec: Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
- Recall number
- Z-1111-2019
- Recalling firm
- Beaver Visitec
- Product
- Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
- Status
- Terminated
- Initiated
- 2019-03-12
- Posted
- 2019-04-09
- Terminated
- 2020-08-11
- Reason
- Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device
- Root cause
- Packaging process control
- Action
- Beaver-Visitec International, Inc.(BVI) initiated recall by letter on 3/12/19 advising users of the problem, action to take: immediately examine inventory and quarantine product from this lot subject to mplete and return the enclosed Product Recall Notice Response & Return Form recall, Return ALL quarantined product from the affected lot. Questions you may contact our Customer Service Team at:ClaimsUS@bvimedical.com or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday).
- Quantity
- 196 boxes (10units/box)
- Distribution
- Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS
- Lot, serial or model codes
- Lot Number: 6008554
- 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