Medical Device Recalls

Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ90500

MEDLINE INDUSTRIES, LP - Northfield

Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus

Microbiologics Inc

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Num

MEDLINE INDUSTRIES, LP - Northfield

Acrobat-i Vacuum Positioner System, Model Number XP-5000Z

Maquet Cardiovascular, LLC

Open Shoulder, LWOS39L; Medical convenience kit

American Contract Systems, Inc.

Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A

Medtronic Neuromodulation

Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes

Olympus Corporation of the Americas

Acrobat-i Positioner. Model Number C-XP-5000Z

Maquet Cardiovascular, LLC

MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the v

Angiodynamics, Inc.

Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300

Barco N.V.

Model Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray system

SEDECAL SA

BD Alaris PCU REF 8015

CareFusion 303, Inc.

Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C

Diasol, Inc

Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION

MEDLINE INDUSTRIES, LP - Northfield

nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosi

Landauer

VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The V

Merge Healthcare, Inc.

KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway.

King Systems Corp. dba Ambu, Inc.

Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c

MEDLINE INDUSTRIES, LP - Northfield

Medline procedure kits, labeled as: HAND, REF DYNJ902002J

MEDLINE INDUSTRIES, LP - Northfield

STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental

Stradis Medical, LLC dba Stradis Healthcare

Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157

Mckesson Medical-Surgical Inc. Corporate Office

MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic Homecare Bed, 4-pac

Medline Industries, LP

LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw

Integrity Implants Inc.

INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS

Wright Medical Technology Inc

Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120

C.R. Bard Inc

INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT402

Medtronic Sofamor Danek USA Inc

Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL

Mckesson Medical-Surgical Inc. Corporate Office

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a

Getinge Usa Sales Inc

iLet Bionic Pancreas, REF: BB1001

Beta Bionics, Inc.

BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a

CareFusion 303, Inc.