Medical Device Recalls

Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE

Cardinal Health 200, LLC

QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalacti

Microbiologics Inc

Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

Paragon 28, Inc.

GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S

Ohio Medical Corporation

Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imagi

GE Medical Systems, LLC

OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide

GE OEC Medical Systems, Inc

Revolution Apex, Revolution CT with Apex Edition

GE Healthcare, LLC

p-Chip Wand Reader

p-Chip Corporation

Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.

Corin Ltd

Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - Al

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following produ

Philips North America, LLC

Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

Siemens Medical Solutions USA, Inc

TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter

GE Healthcare Finland Oy

MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-00000

Auris Health, Inc

Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pac

MEDLINE INDUSTRIES, LP - Northfield

Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDO

Medline Industries, LP

Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test r

Church & Dwight Inc

A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 77070806

Tyber Medical

a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Per

Mckesson Medical-Surgical Inc. Corporate Office

Model Number L231, PROPONENT DR EL MRI Pacemaker

Boston Scientific Corporation

Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.

Cardinal Health 200, LLC

Alaris Pump Module Model 8100, a modular infusion pump and monitoring system

CareFusion 303, Inc.

TENACIO Pump without InhibiZone; UPN: 72404420;

Boston Scientific Corporation

GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Airway Exam Kit, DYKE1796

Medline Industries, LP

ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/

CareFusion 303, Inc.

Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.

Aizu Olympus Co., Ltd.

Paradigm Insulin Pump (MMT-712, MMT-715)

Medtronic MiniMed, Inc.

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, M

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)