Data Foundry

Medical device recalls 2026

BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106… — Class II medical device recall Z-2514-2026

Ongoing recall by BD SWITZERLAND SARL, reported 2026-06-24, distributed in AK, AL, AR, AZ, CA, CO, DC, FL…. Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread o

Recall numberZ-2514-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmBD SWITZERLAND SARL, Eysins, Switzerland
Recall initiated2026-05-21
Classified2026-06-18
Reported by FDA2026-06-24
DistributedAK, 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, WV
Countries outside the USJP
Quantity2,465,500 units
UPC / GTIN / UDI-DI00382903949106
Lot numbers4277968, 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 and 1 more
Model numbers394910

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2514-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.