Medical Device Recalls

Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualizat

Ambu Inc.

Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia w

CooperVision, Inc.

ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245

MEDLINE INDUSTRIES, LP - Northfield

Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)

Freudenberg Medical, Llc

Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.

Olympus Corporation of the Americas

Cardiosave Hybrid

Datascope Corp.

Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Sof

Rocket Medical Plc

(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ90

MEDLINE INDUSTRIES, LP - Northfield

Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnosti

Noah Medical

SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

Beckman Coulter Inc.

Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system

Leica Microsystems, Inc.

ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A;

Sklar Instruments

Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2

Whele LLC DBA Perch

1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen

Bard Access Systems, Inc.

ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

ICU Medical, Inc.

Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1

SunMed Holdings, LLC

Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.

Getinge Usa Sales Inc

Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog N

Dexcom, Inc.

CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A

CardioQuip, LLC

BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

Smith & Nephew Inc.

Express Mini 500 Dry Seal Chest Drain, Part Number 16400

Atrium Medical Corporation

BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231758¿

Becton Dickinson & Co.

11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-

Karl Storz Endoscopy

1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. S

Siemens Medical Solutions USA, Inc

Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description

Alcon Research LLC

Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230

Becton Dickinson & Co.

SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use on

GE Medical Systems, LLC

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC

Cordis US Corp