FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
- Recall number
- Z-1496-2026
- Recalling firm
- Becton Dickinson & Company
- Product
- 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
- Status
- Open, Classified
- Initiated
- 2026-01-27
- Posted
- 2026-03-06
- Terminated
- not on file
- Reason
- During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
- Root cause
- Under Investigation by firm
- Action
- Becton Dickinson notified consignees on about 01/27/2026 via emailed URGENT: Medical Device Recall (Correction) letter. Consignees were instructed to visually verify that the correct syringe is selected for the intended clinical application prior to use and that it forms a secure connection, destroy any luer slip syringes found in inventory, circulate the notification to all personnel who need to be aware or to any organization where the potentially affected products have been transferred, and complete and return the provided Customer Response Form. Distributors and kit manufactures were instructed to identify all customers within their distribution network that purchased any affected product and provide a copy of the customer letter to all customers to advise them of this field action notification on BD s behalf. Becton Dickinson is investigating the root cause and will take corrective actions to prevent recurrence of the issue as well as will provide replacement for all discarded inventory.
- Quantity
- 204,000 units
- Distribution
- US Nationwide distribution in the states of California and Texas.
- Lot, serial or model codes
- Catalog Number: 301029., UDI-DI: N/A. Lot Number: 5268614. Expiration Date: 08/31/2030.
- 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