BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Reported: November 26, 2025 Initiated: October 14, 2025 #Z-0504-2026
Product Description
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Reason for Recall
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Details
- Recalling Firm
- Becton Dickinson & Company
- Units Affected
- 4180000 units
- Distribution
- 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.
- Location
- Franklin Lakes, NJ
Frequently Asked Questions
What product was recalled? ▼
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;. Recalled by Becton Dickinson & Company. Units affected: 4180000 units.
Why was this product recalled? ▼
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2025. Severity: Moderate. Recall number: Z-0504-2026.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11