CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report
BD Luer Tip Caps recalled by Becton Dickinson &
Becton Dickinson is recalling BD Luer Tip Caps, distributed nationwide in the US. The recall was initiated on 14 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0504-2026
- FDA event ID
- 97737
- Recalling firm
- Becton Dickinson, Franklin Lakes, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Oct 2025
- FDA classified
- 14 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Oct 2025 | Recall initiated by company | |
| 14 Nov 2025 | Classified by FDA | +31 days |
| 26 Nov 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Product as listed by the FDA
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Where it was distributed
Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, Singapore, Hong Kong.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth CarolinaNebraska
Questions about this recall
Why was it recalled?
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Which lots are affected?
Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;
Where was it sold?
Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, Singapore, Hong Kong.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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