10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
FDA device recall Z-1496-2026 · posted 2026-03-06 · Open, Classified
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FMF
- Quantity affected
- 204,000 units
- Distribution
- US Nationwide distribution in the states of California and Texas.
- Date initiated
- 2026-01-27
- Date posted
- 2026-03-06
- Location
- Franklin Lakes, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BECTON DICKINSON SYRINGE (K980987) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-06-11 |