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FDA Medical Device Recalls (openFDA)

Becton Dickinson & Company: BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA.

Recall number
Z-1811-2009
Recalling firm
Becton Dickinson & Company
Product
BD 60ml Syringe Luer-Lok tip, Sterile, BD, Franklin Lakes, NJ 07417, Made in USA.
Status
Terminated
Initiated
2009-07-07
Posted
2009-08-12
Terminated
2009-10-02
Reason
Insufficient Seal: Becton Dickinson received complaints of insufficient/open seals on one lot of 60 ml Luer-Lok Syringes.
Root cause
Packaging process control
Action
Becton Dickinson issued an "Urgent: Product Recall" notice via UPS tracking dated July 7, 2009 to all distributors informing them of the affected product. The firm asked all distributors to identify end customers in an attempt to notify all customers. The firms asks that all affected product be returned. Further questions should be directed to BD Customer Service representatives at 1-888-237-2762.
Quantity
133,600 units
Distribution
Nationwide Distribution -- Including states of IL, CA, VA, PA, and FL.
Lot, serial or model codes
Product Number: 309653; Lot Number: 819101A.
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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