CLASS II ONGOING Device recall · Reported 18 Oct 2023 · FDA Enforcement Report

BD Bactec Plus Aerobic/F Culture Vials recalled by Becton Dickinson &

Becton Dickinson & is recalling BD Bactec Plus Aerobic/F Culture Vials, distributed nationwide in the US. The recall was initiated on 12 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 038290HXRPGWNNMN; Lot Numbers: 3062843 3062846 3062849 3062847 3067489 3067488

Quantity recalled781,600 vials

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-0110-2024
FDA event ID: 93097
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class II
Status: Ongoing
Recall initiated: 12 Sep 2023
FDA classified: 12 Oct 2023
Reported: 18 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

12 Sep 2023	Recall initiated by company
12 Oct 2023	Classified by FDA	+30 days
18 Oct 2023	Published in enforcement report	+6 days

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

Reason for recall

Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial.

Product as listed by the FDA

BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Is BD Bactec Plus Aerobic/F Culture Vials recalled?

Yes. Becton Dickinson & recalled BD Bactec Plus Aerobic/F Culture Vials on 12 Sep 2023. The recall is Class II and its status is Ongoing. Recall number Z-0110-2024.

Why was it recalled?

Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial.

Which lots are affected?

UDI-DI: 038290HXRPGWNNMN; Lot Numbers: 3062843 3062846 3062849 3062847 3067489 3067488

Where was it sold?

Worldwide - US Nationwide distribution.

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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