Medical Device Recalls

SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Ima

GE Medical Systems, LLC

The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shap

Stryker Neurovascular

Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United State

Respironics California, LLC

Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinic

Intuitive Surgical, Inc.

SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product D

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;

MEDLINE INDUSTRIES, LP - Northfield

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Nu

MEDLINE INDUSTRIES, LP - Northfield

Allia IGS 3 Pulse angiographic X-ray system

GE Medical Systems, LLC

Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746

Medline Industries, LP

Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;

PHILIPS MEDICAL SYSTEMS

GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPA

MEDLINE INDUSTRIES, LP - Northfield

Non-ablative Fractional Laser Systems, Model: WFB-01

WINGDERM ELECTRO-OPTICS LTD.

Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z

Maquet Cardiovascular, LLC

AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740

Boston Scientific Corporation

Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

Diversatek Healthcare

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH4

American Contract Systems Inc

Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

Cepheid

React Health PHOENIX 5L Oxygen Concentrator

3B Medical, Inc.

Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

Alere San Diego, Inc.

Medtronic, Simplera Sensor, REF: MMT-5100JD1

Medtronic MiniMed, Inc.

TRACH KIT W/HYDROGEN & SALI

Cardinal Health 200, LLC

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ

MEDLINE INDUSTRIES, LP - Northfield

Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714

Young Dental Manufacturing I, LLC

Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79

SEASPINE ORTHOPEDICS CORPORATION

Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.

Maquet Cardiovascular, LLC

Sensis Vibe Hemo

Siemens Medical Solutions USA, Inc

Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated an

Siemens Healthcare Diagnostics, Inc.

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic

GE Healthcare, LLC