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: 2031581, Exp. Date: 2031581

Quantity recalled80,500 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-1243-2023
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, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326719

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

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: 2031581, Exp. Date: 2031581

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

Other products in this recall event

7 other products · FDA event 91495

This product is part of a recall event; the main page for the event is BD Ultra-Fine Insulin Syringe-Insulin Syringes are designed recalled.

Reported	Class	Recall	Company	Reason	Where
22 Mar 2023	CLASS II	BD Ultra-Fine Insulin Syringe-Insulin Syringes are designed recalled	Becton Dickinson	Sterility	Nationwide
22 Mar 2023	CLASS II	BD Insulin Syringes with the BD Micro-Fine IV Needle Single recalled	Becton Dickinson	Sterility	Nationwide
22 Mar 2023	CLASS II	BD Ultra-Fine Insulin Syringe recalled by Becton Dickinson &	Becton Dickinson	Sterility	Nationwide
22 Mar 2023	CLASS II	BD Ultra-Fine II Insulin Syringe-Insulin Syringes recalled	Becton Dickinson	Sterility	Nationwide
22 Mar 2023	CLASS II	BD Insulin Syringes with the BD Micro-Fine IV Needle recalled	Becton Dickinson	Sterility	Nationwide
22 Mar 2023	CLASS II	BD Ultra-Fine Insulin Syringe-Insulin Syringes are designed recalled	Becton Dickinson	Sterility	Nationwide
22 Mar 2023	CLASS II	BD Insulin Syringes with the BD Micro-Fine TM IV Needle recalled	Becton Dickinson	Sterility	Nationwide

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10 Jun 2026Device	CLASS I	BD¿Spinal Tray with BD¿Whitacre Needle recalled by Becton Dickinson &	Becton Dickinson	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS I	BD¿Spinal Tray with BD¿Whitacre Needle, BD¿Quincke Needle recalled	Becton Dickinson	Processing Deviation	Nationwide

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