FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: 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
- Recall number
- Z-0923-2021
- Recalling firm
- Becton Dickinson & Company
- 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
- Status
- Terminated
- Initiated
- 2020-12-09
- Posted
- not on file
- Terminated
- 2022-08-10
- Reason
- 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
- 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 BDRC17@bd.com 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
- 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
- Lot, serial or model codes
- All lots within expiration date UDI: (01)50382904042047
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28