FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
- Recall number
- Z-1109-2021
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
- Status
- Terminated
- Initiated
- 2020-12-23
- Posted
- not on file
- Terminated
- 2022-11-21
- Reason
- The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.
- Root cause
- Process control
- Action
- On 01/13/2020 BD issued an Urgent Medical Device Recall notices to distributors via letters and via e-mail. Distributors are requested to identify their customers and provide BD a customer list so that BD can undertake further communication to the users. BD will distribute the recall communication to the distributors customers via FedEx upon receiving the customer information from the distributors. A copy of the BD product recall customer letter will be provided to distributors, in the case they opt to contact their customers directly.
- Quantity
- 155,200 needles
- Distribution
- Distribution US nationwide and Canada
- Lot, serial or model codes
- Catalog (Ref No.) 305482 100/package UDI 00382903054824 Lot # 8142303 exp date 31-May-2023
- 510(k) numbers
- ["K980987"]
- PMA numbers
- not on file
- Product code
- FMF
- 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