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FDA Medical Device Recalls (openFDA)

Becton Dickinson & Company: BD Syringes - #309585 -- Piston Syringe, Syringe 3ML LL Syringe.

Recall number
Z-1053-05
Recalling firm
Becton Dickinson & Company
Product
BD Syringes - #309585 -- Piston Syringe, Syringe 3ML LL Syringe.
Status
Terminated
Initiated
2005-05-25
Posted
2005-07-28
Terminated
2005-12-02
Reason
The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
Root cause
Other
Action
BD contacted their customers via phone and overnight mail letter . End users were notified by overnight mail with confirmation of delivery.
Quantity
691200 units
Distribution
BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.
Lot, serial or model codes
Affected Lot  309585 Syringe 3ML LL Syringe only Lot 5064003
510(k) numbers
not on file
PMA numbers
not on file
Product code
FMF
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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