FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD AutoShield Pen Needle (Re order Number : 329300)
- Recall number
- Z-0838-2007
- Recalling firm
- Becton Dickinson & Company
- Product
- BD AutoShield Pen Needle (Re order Number : 329300)
- Status
- Terminated
- Initiated
- 2007-04-23
- Posted
- 2007-05-24
- Terminated
- 2008-04-16
- Reason
- Needle Sticks: Complaints were received regarding Needle Stick Injuries while administering insulin to patients. (Labeling will be revised to provide clear direction on product usage)
- Root cause
- Other
- Action
- April 23, 2007, Recall letters were sent via UPS 2nd day air and/or hand delivered to all direct consignees and potential customers of the product.
- Quantity
- 496,200 units
- Distribution
- Nationwide :Distribution centers in NJ, MO, TX, OH, NM, IL, ND, FL, KS, VA, LA, and GA.
- Lot, serial or model codes
- Reorder Number 329300
- 510(k) numbers
- ["K060007"]
- PMA numbers
- not on file
- Product code
- FMI
- 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
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