The Recall Desk
HighFDA (Devices)·Z-1237-2023·Announced 2023-03-22

BD Ultra-Fine Insulin Syringe Recall Due to Nonsterile Manufacturing

Becton Dickinson is recalling 45,000 units of BD Ultra-Fine Insulin Syringes (catalog 326679, lot 2164338) due to nonsterile manufacturing that could expose patients to pathogenic microorganisms and local infection. Distribution was worldwide.

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 FDA Class II recall involves a nonsterile medical device with potential exposure to pathogenic microorganisms. The source text indicates a risk of local infection but does not report any illnesses or injuries, making this a theoretical risk-of-harm scenario that meets the threshold for a High severity rating.

Plain-English summary

Becton Dickinson & Company is recalling 45,000 units of BD Ultra-Fine Insulin Syringes (0.5mL, 6mm, 31G, catalog number 326679) due to a manufacturing defect. The affected products are lot number 2164338 with an expiration date of August 31, 2027. These syringes are medical devices designed to administer insulin for the treatment of diabetes mellitus.

The recall was initiated because the syringes were manufactured nonsterile. Nonsterile syringes create a potential for patients to be exposed to pathogenic microorganisms, which poses a risk of local infection at the injection site.

The affected syringes were distributed worldwide, including throughout the United States and in 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 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326679
Manufacturer
Becton Dickinson & Company
Category
Medical Device — Insulin Delivery / Syringes
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 (1)

  • UDI_DI: N/A Lot Number: 2164338 Exp Date: 20270831

Distribution

Distributed nationwide across the United States.

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