Medical Device Recalls

BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEM

BioPro, Inc.

DEXLOCK Achilles Repair Implant Kits, MAKT4520

Medline Industries, LP

ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabiliz

Zimmer, Inc.

Anesthesia Circuit Kit Coax HEPA, MP17102

Draeger Medical, Inc.

VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01

Biomerieux Inc

Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,

Iradimed Corporation

Alinity m System, Part No. 08N53-002

Abbott Molecular, Inc.

FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

GM85 Digital Mobile X-ray imaging System; Model Number: GM85;

NeuroLogica Corporation

Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light sou

Olympus Corporation of the Americas

Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.

Philips North America

EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model

Datex-Ohmeda, Inc.

Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound

Oakworks Inc

Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NE

MEDLINE INDUSTRIES, LP - SPT

GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09

DeRoyal Industries Inc

Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes wit

Jiangsu Shenli Medical Production Co., Ltd.

INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE

Canon Medical System, USA, INC.

COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator

Medtronic Inc.

Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restoration

IVOCLAR VIVADENT AG

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910

Howmedica Osteonics Corp.

RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206

Biomet, Inc.

One Step UTI in vitro diagnostic test REF: 3374

DFI Co., Ltd.

Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/

MEDLINE INDUSTRIES, LP - Northfield

Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR T

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008

MEDLINE INDUSTRIES, LP - Northfield

MAGEC 1 System

NuVasive Specialized Orthopedics, Inc.

Centricity Universal Viewer Workflow Manager, Image processing radiological system

GE Healthcare

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring o

Instrumentation Laboratory

MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808

Medline Industries, LP