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FDA Medical Device Recalls (openFDA)

Becton Dickinson & Company: BD 60 ml Syringe, Luer-Lok Tip Sterile; Cases : 160 (4 x 40) Shelf Carton: 40 BD; Franklin Lakes, NJ 07417 USA. Made in USA. Syringes for use in aspiration and injection of medications.

Recall number
Z-2374-2008
Recalling firm
Becton Dickinson & Company
Product
BD 60 ml Syringe, Luer-Lok Tip Sterile; Cases : 160 (4 x 40) Shelf Carton: 40 BD; Franklin Lakes, NJ 07417 USA. Made in USA. Syringes for use in aspiration and injection of medications.
Status
Terminated
Initiated
2008-07-15
Posted
2008-09-18
Terminated
2009-04-16
Reason
Becton Dickinson identified the presence of open seals during an internal inspection process.
Root cause
Package design/selection
Action
Urgent: Product Recall letters were sent to Distributors and Syringe Customers on July 15, 2008 by UPS second day air. Customers are to immediately review their inventory, determine if they have any affected product, and remove the affected if they have any. Next customers should complete the enclosed Customer Packing List and BD will send a replacement product upon receipt of the returned product. Questions are to be directed to BD Customer Service at 1-888-237-2762, M-F, 8:00 AM to 5:00 PM EST.
Quantity
1246 lots
Distribution
Nationwide Distribution.
Lot, serial or model codes
Reorder Number: 309653; Lot numbers beginning with the numbers 5, 6, or 7 and also the following lot numbers. 8010954, 8014571, 8031115, 8031117, 8031119, 8031124, 8031133, 8038154, 8038158, 8045564, 8045567, 8058890, 8058896, 8058898, 8058900, 8058902, 8072401, 8072409, 8072414, 8072419, 8079645, and 8079656.  Note: In order to make the recall practical for customers to implement, BD has requested the return of lots beginning with the numbers 5,6 or 7. while not all lots beginning with the digits 5,6 and 7 exhibit the issue, it is much easier to instruct customers to return these lots, rather than have customrs examine/check a more comprehensive list of affected and unaffected lots.
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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