The Recall Desk
HighFDA (Devices)·Z-1937-2016·Announced 2016-06-15

Becton Dickinson Recalls 10 mL Syringes Due to Manufacturing Non-Conformities

Becton Dickinson is recalling 811,200 units of 10 mL syringes due to possible adulteration and non-conforming manufacturing practices.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with possible adulteration and non-conforming manufacturing practices, which poses a risk of harm, but the source text does not report any illnesses or injuries, meeting the criteria for a High severity score.

Plain-English summary

Becton Dickinson & Company is recalling 811,200 units of Henry Schein Single Use Syringe Luer-Lock, 10 mL, and BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm). These products are intended for use by health care professionals for general purpose fluid aspiration and injection.

The recall was initiated due to possible adulteration and non-conforming manufacturing practices. The affected products were distributed nationwide to New York only. The specific catalog number is 309642, and the affected lot numbers are 4163814, 4252723, 4252726, 4252729, 4293878, 4340516, 5017729, and 5017735.

Health care professionals should check their inventory for these specific lot numbers and stop using the affected syringes. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
Affected units
811,200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Catalog (REF #) 309642
  • Lot #'s 4163814
  • 4252723
  • 4252726
  • 4252729
  • 4293878
  • 4340516
  • 5017729 and 5017735

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →