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

BD Insulin Syringes with the BD Micro-Fine IV Needle recalled

Becton Dickinson & is recalling BD Insulin Syringes with the BD Micro-Fine IV Needle Two Unit Scale- Insulin Syringes are, 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 : (01) 00382903294244 Lot Number: 2024074 Exp. Date: 2024074; Lot Number: 2045195 Exp. Date: 20270430

Quantity recalled1,921,000 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-1239-2023
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 Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329424

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 Insulin Syringes with the BD Micro-Fine IV Needle Two Unit Scale- Insulin Syringes are recalled?

Yes. Becton Dickinson & recalled BD Insulin Syringes with the BD Micro-Fine IV Needle Two Unit Scale- Insulin Syringes are on 1 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1239-2023.

Why was it recalled?

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

Which lots are affected?

GTIN : (01) 00382903294244 Lot Number: 2024074 Exp. Date: 2024074; Lot Number: 2045195 Exp. Date: 20270430

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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