CLASS II Device recall · Reported 3 Feb 2021 · FDA Enforcement Report

BD Regional Block Needles/cs.) recalled by Becton Dickinson &

Becton Dickinson & is recalling BD Regional Block Needles/cs.), distributed in 18 states. The recall was initiated on 9 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots within expiration date UDI: (01)50382904083484

Quantity recalled105880 units US

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-0924-2021
FDA event ID: 86994
Recalling firm: Becton Dickinson &, Franklin Lakes, NJ
Classification: Class II
Status: Terminated
Recall initiated: 9 Dec 2020
FDA classified: 26 Jan 2021
Reported: 3 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

9 Dec 2020	Recall initiated by company
26 Jan 2021	Classified by FDA	+48 days
3 Feb 2021	Published in enforcement report	+8 days

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

Reason for recall

BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications

Product as listed by the FDA

BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 408348

Where it was distributed

Alabama, Connecticut, Florida, Illinois, Indiana, Michigan, Missouri, Mississippi, North Carolina, Nebraska, Nevada, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia. Foreign: Australia, Canada, Belgium and Singapore

Alabama Connecticut Florida Illinois Indiana Michigan Missouri Mississippi North Carolina Nebraska Nevada New York Pennsylvania Rhode Island Tennessee Texas Utah Virginia

Questions about this recall

Is BD Regional Block Needles/cs.) recalled?

Yes. Becton Dickinson & recalled BD Regional Block Needles/cs.) on 9 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-0924-2021.

Why was it recalled?

BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications

Which lots are affected?

All lots within expiration date UDI: (01)50382904083484

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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