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FDA Medical Device Recalls (openFDA)

Beaver Visitec: Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.

Recall number
Z-2740-2018
Recalling firm
Beaver Visitec
Product
Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
Status
Terminated
Initiated
2018-06-18
Posted
not on file
Terminated
2019-10-30
Reason
Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.
Root cause
Packaging process control
Action
BVI issued PRODUCT RECALL NOTICES to customers dated June 11, 2018. Customers were instructed to inspect stock, quarantine and destroy product per internal procedures. BVI is kindly asking the customers to provide objective evidence of product destruction so that a credit can be applied to accounts. Customers are also encouraged to complete and return the response form. If you have questions regarding this recall please call Customer Service at 866-906-8080.
Quantity
440
Distribution
Distribution to US states of CA, IL, MD, MN, NJ, OH & PA; and Israel
Lot, serial or model codes
Lot Number 6001700
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

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