Medical Device Recalls

nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiation monitoring dosi

Landauer

Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

25GA Subretinal Injection Cannula VS0220.25

Vortex Surgical Inc.

Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304

Cardinal Health 200, LLC

Alinity m HBV Application Specification File (US and CE)

Abbott Molecular, Inc.

Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number

MEDLINE INDUSTRIES, LP - Northfield

Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC

North Coast Medical Inc

VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)

Ortho-Clinical Diagnostics, Inc.

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V;

Augustine Temperature Management, LLC

MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 I

MEDLINE INDUSTRIES, LP - Northfield

Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access o

Magnolia Medical Technologies, Inc.

Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T

TELEFLEX MEDICAL INC

Sterile Procedural Trays, labeled as the following: IM NAIL

MEDLINE INDUSTRIES, LP - Northfield

Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w

AURIS HEALTH INC

STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray

Stradis Medical, LLC dba Stradis Healthcare

FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

BioFire Diagnostics, LLC

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190

Olympus Corporation of the Americas

ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy devi

MICROVENTION INC.

ZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701M

Zeus Scientific, Inc.

Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015

Stryker Corporation

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked

Acon Biotech (Hangzhou) Co., Ltd.

Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.

Oculus Optikgeraete GMBH

RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combinatio

RAYSEARCH LABORATORIES AB

Achieva 3.0T for PET, Magnetic Resonance System.

Philips North America Llc

Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.

Elekta, Inc.

Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Mo

Invacare Corporation

Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910

Howmedica Osteonics Corp.

Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and intervent

Siemens Medical Solutions USA, Inc

Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOP

MEDLINE INDUSTRIES, LP - Northfield

ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators

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