Z-0923-2021Class II

BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect...

Name: Z-0923-2021 BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect...
Creator: Becton Dickinson & Company
Published: 2020-12-09
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2020-12-09 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Company began a recall of BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical... on 2020-12-09. FDA classified it as Class II and gives the reason as "BD was advised by the European Notified Body, NSAI, that the instructions for use (IFU) needs to be updated to include the general contraindications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0923-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-09
Posted: 2021-01-26
Terminated: 2022-08-10
Recalling firm: Becton Dickinson & Co
Product: BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 404204
Product code: N/A
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
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: BD issued Urgent Medical Device notification on 12/9/20 to Distributors, Hospitals stating reason for recall, health risk and action to take: Immediately review your inventory for the specific Catalog numbers listed above. 2. As BD plans to notify all affected customers directly, please identify customers within your distribution network that purchased the affected product, as defined in this recall notification. Email an excel file listing of all customers to [email protected] within 72 hours of receipt of this letter so that BD may initiate customer notification. 3. Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 4. A copy of the customer communication is attached for your reference. Customer/Technical Support (844) 823-5433 MonFri 8:30am and 5:00pm (EST) For customers outside the US, contact your local BD representative or distributor.
Quantity in commerce: US: 16250 units
Distribution: 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
Product codes and lots: All lots within expiration date UDI: (01)50382904042047

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0923-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0923-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-26
Z-0924-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-26

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)