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FDA Medical Device Recalls (openFDA)

Becton Dickinson & Company: Microtainer Safety Flow Lancets; Blue Sterile Use once and Discard; 1.9mm Blade Length; 1.0 mm Blade Width; Becton Dickinson Vacutainer Systems Becton dickinson and COmpany; Franklin Lakes, NJ 07417

Recall number
Z-0046-2008
Recalling firm
Becton Dickinson & Company
Product
Microtainer Safety Flow Lancets; Blue Sterile Use once and Discard; 1.9mm Blade Length; 1.0 mm Blade Width; Becton Dickinson Vacutainer Systems Becton dickinson and COmpany; Franklin Lakes, NJ 07417
Status
Terminated
Initiated
2007-09-26
Posted
2007-10-18
Terminated
2008-01-15
Reason
Potential for the blade and holder assembly to become loose and then separate from the main body of the lancet during the process of disposal.
Root cause
Process design
Action
Recall communication issued on or about 9/28/2007.
Quantity
4,349,000 units
Distribution
Product distributed worldwide to Australia, Brazil, Canada, China, Colombia, Guatemala, Hong Kong, India, Indonesia, Mexico, Malaysia, New Zealand, Pakistan, Philippines, Singapore, Thailand, and United States.
Lot, serial or model codes
Catalog number 366357; Lot numbers: 2228742; 3022532; 3037536; 3055877; 3062548; 3079392; 3086096; 3135003; 3142723; 3199645; 3225646; 3240751; 3248047; 3268651; 2323030; 2330450.
510(k) numbers
not on file
PMA numbers
not on file
Product code
F
Firm FEI
2243072
Firm city
Franklin Lakes
Firm state
NJ
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

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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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