Becton Dickinson & Company BD Luer Tip Caps recall: BD has confirmed through internal testing that certain device trays failed
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
The hazard: Device safety concern
This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.
What the notice says: BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-0504-2026
- Published
- November 26, 2025
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Becton Dickinson & Company
- Product type
- Medical devices
- Units affected
- 4180000 units
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;
- UPC codes
- 50382903083416
Products covered by this recall
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Check your product
The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 50382903083416
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 5029670
- 5034211
- 5041975
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Becton Dickinson & Company — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
Replacements, repairs and reimbursement
Device remedies run through the supply chain, so the route depends on who sold you the unit.
- Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
- If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
- Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
- Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.
Company contact: Becton Dickinson & Company — 1 Becton Dr, Franklin Lakes, NJ, 07417-1815
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Becton Dickinson & Company medical devices recalled?
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 50382903083416; lot code 5029670, 5034211, 5041975. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
Where was the recalled product sold?
It was distributed nationwide.
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