The Recall Desk
HighFDA (Devices)·Z-1936-2016·Announced 2016-06-15

Becton Dickinson Recalls 10 mL Syringes Due to Manufacturing Issues

Becton Dickinson is recalling 176,000 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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where specific injuries or illnesses have not yet been reported in the source text.

Plain-English summary

Becton Dickinson & Company is recalling 176,000 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). The recall is due to possible adulteration and non-conforming manufacturing practices.

The affected products are intended for use by health care professionals for general purpose fluid aspiration and injection. The specific items involved are identified by Catalog (REF #) 9004476 and Lot #4163707.

The source text indicates nationwide distribution to New York only. Health care professionals should stop using the affected lots and contact the manufacturer for further instructions.

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
176,000

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 (2)

  • Catalog (REF #) 9004476
  • Lot #4163707

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 →