CLASS II ONGOING Device recall · Reported 22 Mar 2023 · FDA Enforcement Report

BD Ultra-Fine Insulin Syringe-Insulin Syringes are designed recalled

Becton Dickinson & is recalling BD Ultra-Fine Insulin Syringe-Insulin Syringes are designed for administering insulin in, distributed nationwide in the US. The recall was initiated on 1 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: N/A Lot Number: 2045201, Exp. Date: 20270430; Lot Number: 2073801, Exp. Date: 20270531

Quantity recalled1,168,000 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1241-2023
FDA event ID: 91495
Recalling firm: Becton Dickinson &, Franklin Lakes, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 1 Feb 2023
FDA classified: 10 Mar 2023
Reported: 22 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Syringes & Needles

Timeline

1 Feb 2023	Recall initiated by company
10 Mar 2023	Classified by FDA	+37 days
22 Mar 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326678

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Mexico, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, Thailand, Canada.

Nationwide

Questions about this recall

Is BD Ultra-Fine Insulin Syringe-Insulin Syringes are designed for administering insulin in recalled?

Yes. Becton Dickinson & recalled BD Ultra-Fine Insulin Syringe-Insulin Syringes are designed for administering insulin in on 1 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1241-2023.

Why was it recalled?

Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

Which lots are affected?

GTIN: N/A Lot Number: 2045201, Exp. Date: 20270430; Lot Number: 2073801, Exp. Date: 20270531

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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