Medical Device Recalls

Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

Philips North America Llc

Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B;

MEDLINE INDUSTRIES, LP - Northfield

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000757;

Beaver Visitec International, Inc.

Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF

Medtronic Sofamor Danek USA Inc

Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics

Remel Europe Ltd.

Accelerate PhenoTest BC kit REF 10101018

Accelerate Diagnostics Inc

INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.

Integra LifeSciences Corp. (NeuroSciences)

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a

Biofire Defense

Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic

Given Imaging Ltd.

Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

Fresenius Medical Care Holdings, Inc.

Intelli-C, Right side suspended Tabletop, REF: 03400000

NRT X-RAY A/S

Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.

Philips North America

LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Au

DKK Dai-Ichi Shomei Co., Ltd.

Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)

Medtronic MiniMed, Inc.

Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560

TELEFLEX LLC

Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number:

AVID Medical, Inc.

Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) syste

Dexcom, Inc.

Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 18" 1 LINE (10) Model/Catalog Number: DT-7018-01Q Software Ve

ASP Global, LLC.

Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690

Merit Medical Systems, Inc.

GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed,

GE Healthcare (China) Co., Ltd.

A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the dista

Tyber Medical

Vortex Surgical TID Pharos Illuminated Depressor, VS0801B

Vortex Surgical Inc.

Medline EBSI Kit EBSI1534

Medline Industries, LP

Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28F

Atrium Medical Corporation

Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium

The Anspach Effort, Inc.

Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108

Medline Industries, LP

SOZO Bilateral Arm L-Dex Software

Impedimed Limited

Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) SHOULDER PACK, Medlin

Medline Industries, LP

Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, M

AURIS HEALTH INC

Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 4

ConvaTec, Inc