Z-0504-2026Class II

BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341

Name: Z-0504-2026 BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341
Creator: Becton Dickinson & Company
Published: 2025-10-14
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2025-10-14 / Open, Classified

FDA source

Becton Dickinson & Company began a recall of BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341 on 2025-10-14. FDA classified it as Class II and gives the reason as "BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0504-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-14
Posted: 2025-11-14
Recalling firm: Becton Dickinson & Co
Product: BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
Product code: KYW Container, Liquid Medication, Graduated
Reason for recall: BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
FDA root cause: Under Investigation by firm
Action: 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]
Quantity in commerce: 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.
Product codes and lots: Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0504-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0504-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-14

Product code KYW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)