Medical Device Recalls

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

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

Dexcom, Inc.

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

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

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

Cascade IOMAX Cortical Module, REF: 190296-200

Cadwell Industries Inc

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter

Boston Scientific Corporation

ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code:

ARROW INTERNATIONAL, LLC

TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

Haemonetics Corporation

Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52

HF Acquisition Co LLC

Incisive CT; Software Version Number: 4.5, 5.0, 5.1;

Philips North America Llc

Intera 1.0T Omni/Stellar, Model Number: 781102;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.

Philips North America

Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

Philips North America Llc

Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1

Busse Hospital Disposables, Inc.

Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123

Karl Storz Endoscopy

MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the

Angiodynamics, Inc.

ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S

Olympus Corporation of the Americas