FDA recall record · openFDA

BD SWITZERLAND SARL

8 FDA recalls on record (2024–2025) — 8 device. 8 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at 5

Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or un 1

Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, 1

Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU) 1

Recalls

BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500 Class II 2025-05-12 BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: Class II 2025-05-12 BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA Class II 2025-05-12 Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y Class II 2025-05-12 BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Class II 2025-06-16 BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and Class II 2025-02-20 BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: Class II 2025-05-12 Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set us Class II 2024-04-18

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

Machine-readable: JSON-LD · Markdown