Medical Device Recalls

GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legen

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades

Stryker Corporation

Ellume COVID-19 Home Test

ELLUME LTD

NanoSight LM10 fitted with LM12 module. A laboratory instrument for determination of particle characteristics (e.g. siz

MALVERN PANALYTICAL LTD

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. KIT ROBOT

Medline Industries, LP

EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706

Encore Medical, LP

Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123

Karl Storz Endoscopy

REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL

Abbott Laboratories

BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligamen

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

DeRoyal POSTERIOR LUMBAR FUSION PACK, REF 89-10060.02

DeRoyal Industries Inc

Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis,

GE Healthcare

Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-40

MEDLINE INDUSTRIES, LP - Northfield

FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP

Qualigen Inc

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693,

Siemens Medical Solutions USA, Inc

Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19

AVID Medical, Inc.

CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM R

Accuray Incorporated

Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 15" X 4" 2-LINE (CS 12) GRAY Model/Catalog Number: A7

ASP Global, LLC.

Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE T

Medline Industries, LP

Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualizat

Ambu Inc.

Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia w

CooperVision, Inc.

ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245

MEDLINE INDUSTRIES, LP - Northfield

Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)

Freudenberg Medical, Llc

Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.

Olympus Corporation of the Americas

Cardiosave Hybrid

Datascope Corp.

Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Sof

Rocket Medical Plc

(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ90

MEDLINE INDUSTRIES, LP - Northfield

Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnosti

Noah Medical

SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

Beckman Coulter Inc.

Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system

Leica Microsystems, Inc.