BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks a...

FDA Device Recall #Z-2514-2026 - Class II, May 21, 2026

Recall Summary

Recall Number Z-2514-2026
Classification Class II - Moderate risk
Date Initiated May 21, 2026
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm BD SWITZERLAND SARL
Location Eysins
Product Type Devices
Quantity 2,465,500 units

Product Description

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.

Reason for Recall

Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

Distribution Pattern

U.S.: AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: Japan

Lot / Code Information

Catalog/Model Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4299949 4303841 4305108 4306700 5129635 5129642 5129649 5129650 5129651 5139250 5139251 5139252 5150181 5153940 5164061 5164062 5178078 5181442 5183810 5183816 5183824 5183828 5218287 5218291 5218293 5218299 5218302 5241476 5247729 5247731 5251098 5275601 5275602

Other Recalls from BD SWITZERLAND SARL

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Z-2654-2026 Class II MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Site... Jun 4, 2026
Z-2453-2025 Class II BD PhaSeal Injector Luer (N30C), REF: 515001 B... Jun 16, 2025
Z-1974-2025 Class II BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF... May 12, 2025
Z-1970-2025 Class II Alaris Pump Infusion Set: SmartSite Bag Access... May 12, 2025
Z-1972-2025 Class II BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: M... May 12, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.