Medical Device Recalls

SIGNA PET/MR

GE Medical Systems, LLC

GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4)

GE Healthcare

Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061

MICROspecialties, Inc.

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULAR-LF DYNJ905291B

Medline Industries, LP

AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850

Beckman Coulter Inc.

CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G; Implantable Cardioverter Defibrillators

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

Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

Cordis Corporation

BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Va

CAREFUSION

FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.685

Richard Wolf GmbH

Kaguya Automated Peritoneal Dialysis System

BAXTER HEALTHCARE CORPORATION

EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190

Olympus Corporation of the Americas

ORAL B MOUTH SORE RINSE 237ML, SKU 999087

Family Dollar Stores, Llc.

Lem Fertility LH Ovulation Test (Strip) REF 200-07

Universal Meditech Inc.

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANG

Smiths Medical ASD Inc.

1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K

MEDLINE INDUSTRIES, LP - Northfield

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 099

Datascope Corp.

Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA612

Coloplast Manufacturing US, LLC

Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal

B. Braun Medical, Inc.

Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK,

American Contract Systems, Inc.

RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.

RAYSEARCH LABORATORIES AB

INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

Integra LifeSciences Corp.

ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B

Hiossen Inc.

AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, i

MRP, LLC dba Aquabiliti

4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x

Karl Storz Endoscopy

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left

Waldemar Link GmbH & Co. KG (Mfg Site)

3.2MM Pellet Insertion Tray Catalog Number: B1144

Busse Hospital Disposables, Inc.

Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Vencl

Bard Peripheral Vascular Inc

Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip

Olympus Corporation of the Americas

BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)

Becton Dickinson & Company

Alinity m System, Part No. 08N53-002

Abbott Molecular, Inc.