Medical Device Recalls

Washer Disinfector Aquadis 56; Model Number: 56M

Getinge Disinfection Ab

PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE

Aizu Olympus Co., Ltd.

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product

Olympus Corporation of the Americas

B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dos

B. Braun Medical, Inc.

Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who

Breas Medical, Inc.

Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797

Volcano Corp

Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system

SEDECAL SA

Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessories (simple, powered

SURGIFY MEDICAL OY

Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP12525

US Endodontics, LLC

Achieva 1.5T Initial system Model Number (REF): 781178

Philips North America Llc

Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN

Cardinal Health 200, LLC

Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F ; 2) HAND, Pack Number C

MEDLINE INDUSTRIES, LP - Northfield

Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, C

ROi CPS LLC

OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from

Howmedica Osteonics Corp.

VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915

Biomerieux Inc

COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Or

Cook Incorporated

Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-152

ARROW INTERNATIONAL, LLC

PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips

Universal Meditech Inc.

VITROS XT Chemistry Products TBIL-ALKP Slides

Ortho-Clinical Diagnostics, INc.

EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU

Red Medical Supplies

BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment

Becton Dickinson & Company

Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A; A

ARROW INTERNATIONAL, LLC

BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144

BioFire Diagnostics, LLC

Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only

Abbott Medical

CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit

Caire, Inc.

I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Di

I.T.S. GmbH

Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed qu

Microbiologics Inc

Olympus Bronchovideoscope, Model BF-Q180-AC

Olympus Corporation of the Americas

Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A

Medline Industries, LP

regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit

ROi CPS LLC