Company
BD SWITZERLAND SARL
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
15recalls (4 in 12 months)
12recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2026 | BD SWITZERLAND SARL BD Alaris Pump Infusion Sets
10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites
10015861A 10885403232626 50885403232624 BD Ala Open, Classified |
FPA | K022209 |
| Aug 13, 2026 | BD SWITZERLAND SARL 60 In Non-DEHP Minibore Extension Set RES ME2010
UDI-DI code: 10885403236235
MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C
UDI-DI code: 10885403274619
9 IN Extension Set w/Max Y REF MPX5300- Open, Classified |
FPA | K051499 K083472 |
| Jul 2, 2026 | BD SWITZERLAND SARL MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555
Catalog Number: SAM2461
UDI code: N/A
Engineering Sample/Not for Human Use Open, Classified |
FPA | None listed |
| Jun 18, 2026 | 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 extensi Open, Classified |
FMG | K974083 |
| Aug 27, 2025 | BD SWITZERLAND SARL BD PhaSeal Injector Luer (N30C), REF: 515001
BD PhaSeal Injector Luer Lock (N35), REF: 515003
BD PhaSeal Injector Luer Lock (N35C), REF: 515004
BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 51500 Open, Classified |
ONB | K123213 K130197 +3 |
| Jun 12, 2025 | BD SWITZERLAND SARL BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241;
BD TEXIUM (China), REF: 10012241 CHINA Open, Classified |
FPA | None listed |
| Jun 12, 2025 | BD SWITZERLAND SARL BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500 Open, Classified |
FPA | K053049 |
| Jun 12, 2025 | BD SWITZERLAND SARL 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: MY8030-0006; 60 mL, REF: MY8060-0006 Open, Classified |
FMF | None listed |
| Jun 12, 2025 | BD SWITZERLAND SARL BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060 Open, Classified |
FMF | K071108 |
| Jun 12, 2025 | BD SWITZERLAND SARL Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T;
SmartSite Bag Access Non-Vented Bonded Texium Closed Ma Open, Classified |
FPA | K053049 |
| Apr 2, 2025 | BD SWITZERLAND SARL BD Connecta BD Luer-Lok 360, REF 394910
UDI-DI code: 00382903949106
Connecta Plus 1 and Connecta Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure mo Open, Classified |
FMG | K974083 |
| May 31, 2024 | BD SWITZERLAND SARL Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072
Tubing set used for delivery of fluids, medication, blood and blood products. Open, Classified |
FPA | K022209 |
| Apr 9, 2020 | BD SWITZERLAND SARL BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-s Terminated |
FPA | K811885 |
| Apr 9, 2020 | BD SWITZERLAND SARL BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Terminated |
FPA | K811885 |
| Apr 9, 2020 | BD SWITZERLAND SARL BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Terminated |
FPA | K811885 |