Recall Z-2514-2026 ยท FMG Stopcock, I.V. Set
BD SWITZERLAND SARL
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.
| Date | Jun 18, 2026 (initiated May 21, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 co |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974083 | CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS Ohmeda Medical, Jan 13, 1998 |