The Recall Desk
HighFDA (Devices)·Z-1239-2023·Announced 2023-03-22

BD Insulin Syringes Recalled for Sterility Defect

Becton Dickinson recalls 1.9 million BD Insulin Syringes due to a nonsterility defect that could expose patients to pathogenic microorganisms and local infection risk.

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: FDA Class II recall with no reported illnesses or injuries. The hazard involves a nonsterile syringe with potential for pathogenic infection—a significant risk-of-harm product used for critical insulin administration. Per the rubric, this qualifies as High (3) for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Company is recalling BD Insulin Syringes with the BD Micro-Fine IV Needle (1 ml, 12.7mm, 28G Two Unit Scale, Catalog Number 329424). Approximately 1.9 million units have been distributed worldwide, including throughout the United States, Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, Thailand, and Canada.

The affected syringes may be nonsterile, potentially exposing patients to pathogenic microorganisms and carrying a risk of local infection. The affected lot numbers are 2024074 (expiration 2024074) and 2045195 (expiration April 30, 2027).

Patients and healthcare providers in possession of these syringes should contact Becton Dickinson & Company regarding this recall.

The recalled product

Product
BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329424
Manufacturer
Becton Dickinson & Company
Category
Medical Device — Injection Devices
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) 00382903294244 Lot Number: 2024074 Exp. Date: 2024074
  • Lot Number: 2045195 Exp. Date: 20270430

Distribution

Distributed nationwide across the United States.

Related recalls

Same category