Z-0928-05

BD 25G Spinal Needles. (Spinal Anesthesia Needle)

Name: Z-0928-05 BD 25G Spinal Needles. (Spinal Anesthesia Needle)
Creator: Becton Dickinson & Company
Published: 2005-03-16
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2005-03-16 / Terminated

FDA source

Becton Dickinson & Company began a recall of BD 25G Spinal Needles. (Spinal Anesthesia Needle) on 2005-03-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0928-05
Status: Terminated
Initiated: 2005-03-16
Posted: 2005-06-25
Terminated: 2005-11-07
Recalling firm: Becton Dickinson & Co
Product: BD 25G Spinal Needles. (Spinal Anesthesia Needle)
Product code: BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Reason for recall: 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.
FDA root cause: Other
Action: The firm sent out notification letters on 3/16/2005.
Quantity in commerce: 801580 units
Distribution: The firm uses distributors and ships the product directly to over 4000 hospitals and clinics nationwide.
Product codes and lots: 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.

Product code BSP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)