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U.S. Department of Health and Human Services

Class 2 Device Recall BD Luer Tip Cap

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 Class 2 Device Recall BD Luer Tip Capsee related information
Date Initiated by FirmOctober 14, 2025
Date PostedNovember 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0504-2026
Recall Event ID 97737
Product Classification Container, liquid medication, graduated - Product Code KYW
ProductBD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Code Information Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;
FEI Number 2243072
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactDarren Walsh
201-847-6800
Manufacturer Reason
for Recall		BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn October 14, 2025, URGENT: MEDICAL DEVICE REMOVAL letters were sent to distributors and customers. Please Take the Following Actions: 1. Cease use and destroy any unused affected product according to your facilities regulations. BD will provide credit for all product destroyed. 2. Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification on BD s behalf. 3. Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 5. Report any complaints experienced with the use of this product to BD via the North American Regional Complaint Center: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT Email: productcomplaints@bd.com
Quantity in Commerce4180000 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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