Medical Device Recalls

PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological sam

Entopsis , Inc.

BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respirat

Maquet Medical Systems USA

Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-21142-DMC UDI code

ARROW INTERNATIONAL, LLC

Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE Model/Catalog Number: 91838 Product Description: NON-Sterile syr

Jiangsu Shenli Medical Production Co., Ltd.

Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

Merit Medical Systems, Inc.

Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system

SEDECAL SA

ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 208

DATEX--OHMEDA, INC.

Genesis Screw-In Anchor

Aju Pharm Co., Ltd.

HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3

Devicor Medical Products Inc

Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

Shimadzu Corp. Analytical & Measuring Instruments Div.

SMV BodyTrack, System, Tomography, Computed, Emission

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Us

MEDLINE INDUSTRIES, LP - Northfield

Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A;

MEDLINE INDUSTRIES, LP - Northfield

PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator

Medtronic Inc.

Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue

Olympus Corporation of the Americas

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular ca

Medtronic Perfusion Systems

C5-2 Transducer Probe

Philips Ultrasound, Inc

MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery

Megadyne Medical Products, Inc.

Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypo

Augustine Temperature Management, LLC

3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6,

3M Company - Health Care Business

See complete list in RES, exceeds character limit. Medline Surgical Gowns

Medline Industries, LP

Impella CP Smart Assist Set, EU; Product Code: 0048-0014;

Abiomed, Inc.

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List N

Smiths Medical ASD Inc.

Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case

MEDLINE INDUSTRIES, LP - Northfield

Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/C

Medline Industries, LP

FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA

Ostial Corporation

Incisive CT-Computed Tomography X-Ray System Model: 728143

Philips North America

CovClear COVID-19 Rapid Antigen Test, ATG 900-031

Empowered Diagnostics LLC

RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated a

Randox Laboratories Ltd.