Manufacturer

BD SWITZERLAND SARL

14 recalls in our database name BD SWITZERLAND SARL as the manufacturing or recalling firm.

What the numbers show

Total: 14
Critical: 0
Severe: 1
Most recent: 2026-08-19

Of the 14 recalls from BD SWITZERLAND SARL we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (7%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–14 of 14

HighFDA (Devices)·Z-2941-2026·2026-08-19
BD Medical Extension Sets Recalled for Potential Sterilization Defects
BD Switzerland is recalling 93,700 intravascular extension sets because they may not have received adequate sterilization processing.
Product
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-C UDI-DI code: 10885403237218 Intravascular Administration Set and Extens
Category
Medical Device
Distribution
26 states
ModerateFDA (Devices)·Z-2654-2026·2026-07-08
Medline 111 Gravity Set with Needle Free Y-Sites engineering sample recall
BD Switzerland SARL is recalling a Medline 111 Gravity Set with 3 Needle Free Y-Sites (Catalog Number SAM2461, Lot 25X445) because engineering samples labeled "Not for Human Use" were inadvertently shipped to the U.S. market.
Product
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
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2514-2026·2026-06-24
BD Connecta stopcock Port C may over thread rather than tightening
BD Connecta BD Luer-Lok 360 stopcocks, REF 394910, are being recalled because the Port C connection may over thread or spin rather than tightening securely. 2,465,500 units affected.
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.
Category
Medical Device
Distribution
39 states
ModerateFDA (Devices)·Z-2453-2025·2025-09-03
Drug transfer devices recalled for shipping without US instructions for use
BD PhaSeal closed system drug transfer devices are recalled because they were shipped to the US market without a US version of the instructions for use. 3,884,670 units are affected.
Product
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: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF:
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1972-2025·2025-06-18
BD Texium Closed System Drug Transfer Devices May Leak at Connector
BD Texium closed system drug transfer devices in multiple sizes may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, exposure to hazardous drugs, and underdosing.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1971-2025·2025-06-18
BD Texium Needle-Free Syringe Recalled for Potential Leakage at Luer Interface
BD Texium Needle-Free Syringes (multiple sizes) may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, medication underdosing, or exposure to hazardous drugs.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1970-2025·2025-06-18
Alaris Pump Infusion Sets may leak at male luer connections
BD Switzerland is recalling multiple Alaris Pump Infusion Set models worldwide due to potential leaks at the connection between the closed male luer component and needle-free connector, which could delay procedures, interrupt treatment, expose patients to hazardous drugs, or result in underdosing.
Product
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 Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1973-2025·2025-06-18
BD TEXIUM Closed Male Luer Drug Transfer Device Recall
BD TEXIUM Closed Male Luer devices may leak at the interface between the closed male luer component and needle-free connector. The leak could cause procedure delays, treatment interruptions, exposure to hazardous drugs, and underdosing of medication.
Product
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1974-2025·2025-06-18
BD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk
BD TEXIUM closed male luer drug transfer devices may leak at the interface between the closed male luer component and the needle-free connector, potentially causing procedure delays, treatment interruptions, hazardous drug exposure, and medication underdosing.
Product
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1509-2025·2025-04-09
BD Connecta Stopcocks Recalled for Non-U.S. Instructions Shipped to U.S. Market
BD Connecta Luer-Lok 360 stopcocks were distributed with non-U.S. instructions for use. Healthcare facilities should verify they have the correct U.S. instructions before using affected lot numbers.
Product
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 monitoring.
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1944-2024·2024-06-12
Alaris Pump Infusion Set Drip Chamber May Detach During Use
A defective drip chamber in the Alaris Pump Infusion Set may detach from the tubing, potentially delaying treatment or causing unintended exposure to medications. BD is recalling approximately 11,300 units distributed across the US and Canada.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1968-2020·2020-05-20
BD Alaris PCEA Administration Set Recalled for Potential Leakage
BD Switzerland is recalling 110,350 units of Alaris PCEA Administration Sets due to a potential leak at the luer connection that may cause inadequate pain control.
Product
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 Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1969-2020·2020-05-20
BD Alaris PCEA Administration Set Recalled for Potential Leaking
BD is recalling Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.
Product
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-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1967-2020·2020-05-20
BD Alaris PCEA Administration Set Recalled for Potential Leaking
BD is recalling 110,350 Alaris PCEA Administration Sets because they may leak at the luer connection, potentially causing inadequate pain control.
Product
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 Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA
Category
Medical Device
Distribution
Distributed nationwide