BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.)… recallZ-0923-2021 · Becton Dickinson & Company · initiated Dec 9, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-0923-2021
- Status
- Terminated
- Initiated by the company
- Dec 9, 2020
- Recalling firm
- Becton Dickinson & Company
- Quantity
- US: 16250 units
- Product code
- N/A
- 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 description
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
Code information (models, lots, serial numbers)
All lots within expiration date UDI: (01)50382904042047
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Stimex 404204Becton, Dickinson And Company · Anesthesia conduction kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 86994).
- Z-0924-2021 · TerminatedBD 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). Ca…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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