The Recall Desk
HighFDA (Devices)·Z-1242-2023·Announced 2023-03-22

BD Insulin Syringes Recalled for Nonsterile Condition and Infection Risk

Becton Dickinson is recalling 686,500 units of BD insulin syringes due to a nonsterile condition that may expose patients to pathogenic microorganisms and risk of infection.

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: This is a Class II medical device recall for a sterility defect in insulin syringes. The nonsterile condition creates a risk of pathogenic microorganism exposure and local infection. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported, consistent with a High severity score per the rubric.

Plain-English summary

BD Insulin Syringes with the BD Micro-Fine IV Needle (0.5ml, 12.7mm, 28G, Catalog Number 329461) are being recalled by Becton Dickinson & Company due to a nonsterile condition. The affected product is designed for administering insulin in the treatment of diabetes mellitus.

The nonsterile condition potentially exposes patients to pathogenic microorganisms and poses a risk of local infection. The recall affects 686,500 units with Lot Number 2031528 and expiration date April 30, 2027, which have been distributed worldwide including the United States and countries throughout Central America, South America, Asia, and Canada.

Patients who have received these syringes should contact their healthcare provider if they have concerns about the safety of their insulin administration equipment. The manufacturer and FDA recommend that users stop using the recalled product and consult with their physician about appropriate alternatives.

The recalled product

Product
BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329461
Manufacturer
Becton Dickinson & Company
Category
Medical Device — Syringes / Insulin Administration
Hazard
  • nonsterile
  • pathogenic-microorganism
  • infection-risk

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)

  • GTIN: (01) 00382903294619 Lot Number: 2031528
  • Exp. Date: 20270430

Distribution

Distributed nationwide across the United States.

Related recalls

Same category