Medical Device Recalls

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

Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ688

MEDLINE INDUSTRIES, LP - Northfield

regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit

ROi CPS LLC

MiniMed 720G Insulin Pump (O.U.S. Version)

Medtronic MiniMed

Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316

Avanos Medical, Inc.

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReS

Merit Medical Systems, Inc.

Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814

C.R. Bard Inc

CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable

Baxter Healthcare Corporation

Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F

ARROW INTERNATIONAL, LLC

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/L

Smiths Medical ASD Inc.

ASM Replacement Battery, Component Number SUB0000594

ICU Medical Inc

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01

Linkbio Corp.

Alphenix INFX-8000F, interventional fluoroscopic x-ray system

Canon Medical System, USA, INC.

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

B Braun Medical Inc

GEO-MED BIOPSY TRAY, REF 89-8753.01

DeRoyal Industries Inc

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular cat

Medtronic Perfusion Systems

Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective c

Boston Scientific Corporation

Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm

Covidien LP

Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA -

Getinge Usa Sales Inc

FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D

CooperSurgical, Inc.

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

MEDLINE INDUSTRIES, LP - Northfield

Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associ

Siemens Healthcare Diagnostics, Inc.