Medical Device Recalls

TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog

Howmedica Osteonics Corp.

48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R

Smiths Medical Asd Inc

Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE

Shirakawa Olympus Co., Ltd.

Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator

Hamilton Medical, Inc.

VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 9

Ortho-Clinical Diagnostics, Inc.

Hobbs Medical Cytology Brush Catalog Number: 4204

Hobbs Medical, Inc.

BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural liga

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

SmartPath to dStream for 3.0T Model Number (REF): 782145;

Philips North America

Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C

Diasol, Inc

Intera 1.5T Achieva IT Nova, Magnetic Resonance System.

Philips North America Llc

Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.

Aerin Medical, Inc.

Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femo

Smith & Nephew, Inc.

ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150

Philips North America

DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911

Howmedica Osteonics Corp.

Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.

Abbott

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

Olympus Corporation of the Americas

Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Descript

Edan Diagnostics

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286;

Sklar Instruments

LAVH PACK. Medical convenience kit.

AVID Medical, Inc.

Ziehm Solo. Digital Mobile C-arm

Orthoscan, Inc.

Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 34

Encore Medical, LP

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter

Abbott

Philips eL18-4 Transducer.

Philips Ultrasound, Inc

Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients

Medtronic Navigation, Inc.-Littleton

Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189

Cardinal Health 200, LLC

Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)

Respironics California, LLC

Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS98509

Medline Industries, LP

Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w

AURIS HEALTH INC

HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U

MEDLINE INDUSTRIES, LP - Northfield