BD Ultra-Fine II insulin syringes recalled for sterility defect
Becton Dickinson recalled 1,472,400 BD Ultra-Fine II insulin syringes due to a sterility defect. The nonsterile syringes pose a risk of local infection at injection sites.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 of medical devices with a theoretical risk of local infection due to sterility defects. No illnesses or injuries have been reported to date. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Becton Dickinson & Company recalled 1,472,400 units of BD Ultra-Fine II Insulin Syringes (Catalog Number 326725, 0.5mL, 8mm, 30G) due to a sterility defect in manufacturing.
The syringes were produced as nonsterile, potentially exposing patients to pathogenic microorganisms and creating a risk of local infection at injection sites. The affected product lots are 2010670 (expiration 2031581) and 2052365 (expiration 20270531).
The affected syringes were distributed worldwide, including throughout the United States and internationally to Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, Thailand, and Canada.
Patients should discontinue use of affected syringes and consult their healthcare provider about alternative insulin delivery methods. Healthcare providers and patients with questions should contact Becton Dickinson & Company.
The recalled product
- Product
- BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 1,472,400
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 (3)
- GTIN: N/A Lot Number: 2010670
- Exp. Date:2031581 Lot Number: 2052365
- 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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