FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: # 309603 -- Syringe 5Ml LL syringe.
- Recall number
- Z-1054-05
- Recalling firm
- Becton Dickinson & Company
- Product
- # 309603 -- Syringe 5Ml LL syringe.
- Status
- Terminated
- Initiated
- 2005-05-25
- Posted
- 2005-07-28
- Terminated
- 2005-12-02
- Reason
- The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
- Root cause
- Other
- Action
- BD contacted their customers via phone and overnight mail letter . End users were notified by overnight mail with confirmation of delivery.
- Quantity
- 811200 units
- Distribution
- BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.
- Lot, serial or model codes
- 309603 Syringe 5ML LL Syringe only 5067050; 309603 Syringe 5ML LL Syringe only 5062940
- 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