Medical Device Recalls

Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.

Philips North America Llc

Ziehm Vision RFD. Interventional fluoroscopic x-ray system

Orthoscan, Inc.

Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2)

MEDLINE INDUSTRIES, LP - Northfield

CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web

St. Jude Medical

Octopus Evolution AS Tissue Stabilizer, Model TS2500

Medtronic Perfusion Systems

Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (End

MicroAire Surgical Instruments, LLC

EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilat

Olympus Corporation of the Americas

Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS

Stryker Corporation

BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

Beaver-Visitec International, Inc.

OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, prim

NeuroLogica Corporation

Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV)

B. Braun Medical, Inc.

Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05

AVID Medical, Inc.

Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis

Coloplast Manufacturing US, LLC

ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues.

Smith & Nephew Inc.

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following device

Medtronic Neuromodulation

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained

Zimmer, Inc.

Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002

LUMINOSTICS, INC dba CLIP HEALTH

Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476

Zimmer, Inc.

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.

Smiths Medical ASD, Inc.

1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL

Smiths Medical Asd Inc

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus

B Braun Medical Inc

Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYK

Medline Industries, LP

Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 PORT W/O WASTEBAG,

Medline Industries, LP

Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-L

MEDLINE INDUSTRIES, LP - Northfield

Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Medical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PAC

American Contract Systems Inc.

Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Ste

Jiangsu Shenli Medical Production Co., Ltd.

STERILE BETADINE, REF DYNDA1998

MEDLINE INDUSTRIES, LP - Northfield

Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator

Hamilton Medical, Inc.

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14

Avanos Medical, Inc.