Medical Device Recalls

Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CD

MEDLINE INDUSTRIES, LP - Northfield

Kidney Test

GET TESTED INTERNATIONAL AB

MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545

MEDLINE INDUSTRIES, LP - Northfield

American Contract Systems Biopsy Drape Pack convenience kit

American Contract Systems, Inc.

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03

Linkbio Corp.

CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX o

CORNEAT VISION, LTD.

Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/

Medline Industries, LP

DAC 044 115cm, Catalog: 90760

Stryker Neurovascular

Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S

Merit Medical Systems, Inc.

MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery

Megadyne Medical Products, Inc.

Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S4310

Medtronic Sofamor Danek USA Inc

Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urolo

Boston Scientific Corporation

Identity Shoulder System Resection Planer 35mm Resection Planer

Zimmer, Inc.

WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal

Boston Scientific Corporation

Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.

AVID Medical, Inc.

LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms

Microbiologics Inc

RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as w

RAYSEARCH LABORATORIES AB

Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.

TEI Biosciences, Inc.

CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK

GS Biomark LLC

Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 3

Merit Medical Systems, Inc.

Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005

Stryker Corporation

CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F

Medline Industries, LP

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdinatio

Beckman Coulter, Inc.

Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH

MEDLINE INDUSTRIES, LP - Northfield

Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO BREAST AUGMENTATION PACK DY

Medline Industries, LP

ProxiDiagnost N90; Model Number: 706110;

Philips Medical Systems DMC GmbH

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediat

Oridion Medical 1987 Ltd.

Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010

Howmedica Osteonics Corp.

STRADIS HEALTHCARE, Medical Vein, Item No.682-330,

Stradis Medical, LLC dba Stradis Healthcare

cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid T

Roche Molecular Systems, Inc.