BD Insulin Syringes Recalled for Potential Nonsterile Condition
Becton Dickinson & Company is recalling 1.17 million BD Ultra-Fine Insulin Syringes due to a nonsterile manufacturing defect that could expose patients to pathogenic microorganisms and increase 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: This is an FDA Class II recall involving a sterility defect that creates risk of local infection from pathogenic microorganisms. No hospitalizations or illnesses are reported in the source, placing this as a risk-of-harm product without confirmed injury.
Plain-English summary
Becton Dickinson & Company is recalling approximately 1.17 million BD Ultra-Fine Insulin Syringes (1mL, 6mm, 31G) with Catalog Number 326678 due to a nonsterile manufacturing defect.
The affected syringes were produced in lot 2045201 (expiration 04/30/2027) and lot 2073801 (expiration 05/31/2027). These syringes may be nonsterile and could expose patients to pathogenic microorganisms, creating a risk of local infection.
The syringes have been distributed worldwide, including throughout the United States and to Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, and Thailand.
Patients currently using these syringes should consult with their healthcare provider about obtaining replacements from unaffected lots.
The recalled product
- Product
- BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326678
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Insulin syringe
- Affected units
- 1,168,000
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 (4)
- GTIN: N/A Lot Number: 2045201
- Exp. Date: 20270430
- Lot Number: 2073801
- Exp. Date: 20270531
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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.
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