The Recall Desk
HighFDA (Devices)·Z-1240-2023·Announced 2023-03-22

BD Ultra-Fine Insulin Syringe 0.5mL Recalled for Nonsterility Risk

Becton Dickinson is recalling approximately 1.1 million BD Ultra-Fine Insulin Syringes due to nonsterility concerns. The affected syringes may expose patients to pathogenic microorganisms and risk of local 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: FDA Class II recall of a sterile medical device (insulin syringe) with no reported illnesses or injuries, but presenting risk of infection from nonsterility. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Becton Dickinson & Company has recalled approximately 1.1 million BD Ultra-Fine Insulin Syringe 0.5mL units (Catalog Number 326713) due to nonsterility concerns. The affected syringes may expose users to pathogenic microorganisms and pose a risk of local infection at the injection site.

The recall affects syringes distributed worldwide, including throughout the United States and in Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, Thailand, and Canada. Three specific lot numbers are affected: 2038580, 2063298, and 2137904, all with expiration dates in May or July 2027.

No illnesses or injuries have been reported as of this recall notice. Patients who have used or have in their possession syringes from the affected lots should consult their healthcare provider. Those with affected syringes are advised to stop using them and contact Becton Dickinson or their healthcare provider for guidance on obtaining replacement syringes.

The recalled product

Product
BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326713
Manufacturer
Becton Dickinson & Company
Category
Medical Device — Insulin
Hazard
  • nonsterile
  • infection-risk
  • contamination

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 (5)

  • GTIN: N/A Lot Number: 2038580
  • Exp. Date: 20270531
  • Lot Number: 2063298
  • Lot Number: 2137904
  • Exp. Date: 20270731

Distribution

Distributed nationwide across the United States.

Related recalls

Same category