FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD 25G Spinal Needles. (Spinal Anesthesia Needle)
- Recall number
- Z-0928-05
- Recalling firm
- Becton Dickinson & Company
- Product
- BD 25G Spinal Needles. (Spinal Anesthesia Needle)
- Status
- Terminated
- Initiated
- 2005-03-16
- Posted
- 2005-06-25
- Terminated
- 2005-11-07
- Reason
- A significant level of 25G spinal needle hub leakage complaints was observed. Subsequent investigation found the leakage to be attributable to improper formation of the spinal needle hub, specifically an undersized taper and the prescence of a slight sink in the taper surface.
- Root cause
- Other
- Action
- The firm sent out notification letters on 3/16/2005.
- Quantity
- 801580 units
- Distribution
- The firm uses distributors and ships the product directly to over 4000 hospitals and clinics nationwide.
- Lot, serial or model codes
- Reorder Number, Lot Number: 400440, 4275101; 400440, 4282078; 400440, 4317744; 400479, 3196624; 400479, 4161815; 400479, 4254414; 400479, 4324795; 400496, 4173091; 400590, 3191978; 400590, 4121350; 400621, 4146482; 401586, 3182399; 405078, 3196618; 405078, 4169804; 405078, 4194109; 405078, 4268754; 405078, 4282079; 405078, 4324791; 405078, 4349021; 405138, 4173087; 405138, 4181398; 405140, 3224096; 405140, 4110295; 405140, 4237191; 405140, 4295872, 405140, 4314481; 405140, 4336365; 405170, 4201356; 405170, 4201357 405180, 4096782; 405180, 4145523; 405180, 4148675; 405234, 3174061; 405234, 4062807; 405234, 4105111; 405234, 4163586; 405234, 4265265; 405234, 4282715; 405234, 4282716; 405234, 4314480; 405234, 4358850; 409442, 3174062; 409442, 3226365; 409442, 4110275; 409442, 4121348; 409442, 4230810; 409442, 4230813; 409442, 4257418; 409442, 4300308; 409442, 4320423; 409442, 4329215; 409442, 4349941.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSP
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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