Medical Device Recalls

BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispen

CareFusion 303, Inc.

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION T

MEDLINE INDUSTRIES, LP - Northfield

EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults a

Olympus Corporation of the Americas

BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solut

Young Dental Manufacturing I, LLC

Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF

Trinity Sterile, Inc.

C6-2 Transducer Probe

Philips Ultrasound, Inc

Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e

MEDLINE INDUSTRIES, LP - Northfield

Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400

Aspen Surgical Products, Inc.

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Smith & Nephew, Inc.

Infa-Therm Transport Mattress, Reference Number 989805616831 1015

Philips North America Llc

Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV

GE Medical Systems, LLC

ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;

Abiomed, Inc.

COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator

Medtronic Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001624;

Beaver Visitec International, Inc.

Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.

Philips North America

Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiratio

B. Braun Medical, Inc.

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673

Baxter Healthcare Corporation

LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 m

MICROVENTION INC.

HAND PACK-Procedure Kit Catalog Number: WEHD16B

American Contract Systems Inc

CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators

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

BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, RE

CAREFUSION

LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554

LSL Healthcare Inc.

HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.

Stradis Healthcare

HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatr

Hamilton Medical, Inc.

JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Mod

North American Rescue LLC.

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11

Linkbio Corp.

A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the di

Tyber Medical

Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503

Masimo Corporation

Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS

MEDLINE INDUSTRIES, LP - Northfield