Medical Device Recalls

VIDAS Lyme IgG II (LYM), REF 417401

bioMerieux, Inc.

11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS

Karl Storz Endoscopy

Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, M

Medline Industries, LP

BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

CareFusion 303, Inc.

Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accura

Randox Laboratories Ltd.

MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;

Philips North America

Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patie

Datex-Ohmeda, Inc.

Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical c

Randox Laboratories Ltd.

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-

Sklar Instruments

Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P0

Baxter Healthcare Corporation

QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

Quidel Corporation

General Biospy Tray, REF: GUTS1000

Argon Medical Devices, Inc

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4)

ZOLL Medical Corporation

Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front Software Version: 2.0.11, new version: 2.

Pride Mobility Products Corp.

Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESS

Medline Industries, LP

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CARO

MEDLINE INDUSTRIES, LP - Northfield

Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a dia

Siemens Medical Solutions USA, Inc

VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W

Maquet Cardiovascular, LLC

Ivenix Infusion System (IIS)

Ivenix, Inc.

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D

Medline Industries, LP

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Numbe

Dexcom, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001423;

Beaver Visitec International, Inc.

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-

ARROW INTERNATIONAL, LLC

VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.

MEDLINE INDUSTRIES, LP - Northfield

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170130

TELEFLEX LLC

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree

Wilson-Cook Medical Inc.

CRE Pro Wireguided 10-12mm 240cm

Boston Scientific Corporation

Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) adm

B. Braun Medical, Inc.

Surgicare Neuro Pack - Neurological Kit

Stradis Medical, LLC dba Stradis Healthcare