Agency classClass IIOur severity:High FDA (Devices)·Z-1243-2023·Announced 2023-03-22

BD Ultra-Fine Insulin Syringes Recalled Due to Nonsterile Condition

Becton Dickinson is recalling BD Ultra-Fine Insulin Syringes (Catalog Number 326719) due to a nonsterile condition that could expose patients to pathogenic microorganisms and local infection. Approximately 80,500 units distributed worldwide are affected.

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: FDA Class II recall involving a nonsterile medical device designed for insulin administration. The nonsterile condition poses a risk of infection from pathogenic microorganisms. No illnesses or injuries are reported in the source material, but the risk-of-harm nature of the product warrants a High severity classification per the rubric.

Plain-English summary

Becton Dickinson & Company is recalling BD Ultra-Fine Insulin Syringes (1mL, 12.7mm, 29G, Catalog Number 326719) due to a nonsterile condition. These syringes are designed for administering insulin in diabetes treatment. The nonsterile condition creates a potential risk of exposure to pathogenic microorganisms and local infection.

The recall involves Lot Number 2031581, totaling approximately 80,500 units distributed worldwide. Distribution includes the United States and the following countries: Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, Thailand, and Canada.

The recalled product

Product: BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326719
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Injection Devices
Hazard: nonsterile
pathogenic-contamination
infection-risk
Affected units: 80,500

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: N/A Lot Number: 2031581
Exp. Date: 2031581

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.

See all 8 products in this recall →

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