Medical Device Recalls

VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23

Luminex Corporation

CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3

Caire, Inc.

EVLP Convenience Pack/Kit

Medline Industries Inc

FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)

Karl Storz Endoscopy

Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

SUREPULSE MEDICAL LTD

AlternatiV+ Screw-In Anchor

Aju Pharm Co., Ltd.

FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Mater

Boston Scientific Corporation

Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product

Abbott Medical

Ventana HE 600 System, automated slide preparer, for use in laboratories.

Ventana Medical Systems Inc

AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

Avanos Medical, Inc.

Achieva 1.5T, Magnetic Resonance System.

Philips North America Llc

Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), B

B Braun Medical Inc

Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G

Medline Industries, LP

Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

Fresenius Medical Care Holdings, Inc.

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V

Olympus Corporation of the Americas

Wright EVOLVE TRIAD Plate Cutter, REF 49510120

Wright Medical Technology, Inc.

Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713

Medline Industries, LP

Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050

Covidien LLC

Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177

Philips North America Llc

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Numbe

Encore Medical, LP

Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060

Bard Peripheral Vascular Inc

Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320

Avanos Medical, Inc.

a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 122

Mckesson Medical-Surgical Inc. Corporate Office

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001486;

Beaver Visitec International, Inc.

Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedsid

Edan Diagnostics

REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly

Becton Dickinson Infusion Therapy Systems, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001110;

Beaver Visitec International, Inc.

Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the

Sentinel CH SpA

DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis

Beckman Coulter, Inc.