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FDA Medical Device Recalls (openFDA)

BD Opthalmic Systems: BD Xstar Bevel Up Slit Knife 2.8mm , Sterile Catalog Number: 373728

Recall number
Z-0613-06
Recalling firm
BD Opthalmic Systems
Product
BD Xstar Bevel Up Slit Knife 2.8mm , Sterile Catalog Number: 373728
Status
Terminated
Initiated
2006-02-28
Posted
2006-03-15
Terminated
2006-09-13
Reason
Product labeled as a 2.8 mm may contain a 3.2 mm Xstar slit knife
Root cause
Other
Action
BD Ophthalmic notifIed customers by telephone on 2/28/06 requesting users to examine product and return mislabeled product.
Quantity
3430 units
Distribution
Nationwide Foreign: Belgium
Lot, serial or model codes
Lot Number: 5335524
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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