BD Luer Tip Caps recallZ-0504-2026 · Becton Dickinson & Company · initiated Oct 14, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
FDA root cause category: Under Investigation by firm
What the company is doing
On 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: [email protected]
Recall details
- Recall number
- Z-0504-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 14, 2025
- Posted by the FDA
- Nov 14, 2025
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 4180000 units
- Product code
- KYW
- 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.
Product description
BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Code information (models, lots, serial numbers)
Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Luer Tip Caps 308341Becton, Dickinson And Company · CONTAINER, LIQUID MEDICATION, GRADUATED1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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