Medical Device Recalls

SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examina

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), RE

Carefusion 2200 Inc

ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3

ICU Medical, Inc.

Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILIC

Cardinal Health 200, LLC

X11-4t Transducer Probe

Philips Ultrasound, Inc

Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray

MEDLINE INDUSTRIES, LP - Northfield

REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO,

Becton Dickinson Infusion Therapy Systems, Inc.

Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intende

Wilson-Cook Medical Inc.

Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to

Datex-Ohmeda, Inc.

Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Pro

Datex-Ohmeda Inc

AxiEM" Non-Invasive Patient Tracker

Medtronic Navigation, Inc.

GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system

GE Healthcare (China) Co., Ltd.

cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Num

Roche Molecular Systems, Inc.

W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000

W&H DENTALWERK BUERMOOS GMBH

Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional dev

ROUTE 92 MEDICAL INC

Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.

Olympus Corporation of the Americas

DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postop

DePuy Mitek, Inc., a Johnson & Johnson Co.

Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600

Western/Scott Fetzer Company

ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthet

Hiossen Inc.

MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model

Philips North America Llc

Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOL

MEDLINE INDUSTRIES, LP - Northfield

Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack

MEDLINE INDUSTRIES, LP - Northfield

SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;

Philips North America

Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01

Quest International, Inc.

DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF

Medline Industries, LP

ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471;

Alphatec Spine, Inc.

Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number:

Medline Industries, LP

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20

MEDLINE INDUSTRIES, LP - Northfield

CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through

Maquet Medical Systems USA