Z-2514-2026Class II

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

Name: Z-2514-2026 BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to...
Creator: Bd Switzerland Sarl
Published: 2026-05-21
License: https://open.fda.gov/license/

BD Switzerland SARL / initiated 2026-05-21 / Open, Classified / root cause: design

FDA source

BD SWITZERLAND SARL began a recall of 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... on 2026-05-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2514-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-21
Posted: 2026-06-18
Recalling firm: BD Switzerland SARL
Product: 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.
Product code: FMG Stopcock, I.V. Set
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 05/21/2026, the firm sent via email and FedEx an "URGENT: Medical Device Correction" Letter informing customers that, BD has identified an observed issue in how Port C of the BD Connecta Stopcocks operates during use. Reports received indicate that when using polypropylene plastic luer lock syringes, the connection at Port C may over thread the syringe and continue to spin. This behavior has led some clinical users to perceive the connection as unstable. Actions for Clinical Users: -Per current Instructions for Use: "Do not overtighten connections. Note: Resistance between the male luer connector and the BD Connecta Stopcock when rotating indicates the connection is fully engaged and secure. Instruction to follow: 1.Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. 2.Complete the attached Customer 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. 3.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 4.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] For Questions: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT or Email: [email protected]
Quantity in commerce: 2,465,500 units
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2514-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2514-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-18

Product code FMG

K974083Class IIConnecta Plus 1 and Connecta Plus 3 2-Way and 3-Way StopcocksOhmeda Medical / cleared 1998-01-13

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)