Medical Device Recalls

CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be use

Integra LifeSciences Corp.

Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Pro

B Braun Medical Inc

KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A

American Contract Systems Inc

KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway

King Systems Corp. dba Ambu, Inc.

COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

Lusys Laboratories, Inc.

Baxter Floor mounting column TS 7500 U, Product Code 1730732

Baxter Healthcare Corporation

Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System

Medtronic Inc.

GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premie

GE Medical Systems China Co., Ltd.

intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE P

Biocare Medical, LLC

Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch

Silex Medical, LLC

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

BioFire Diagnostics, LLC

DCA Systems HbA1c Reagent Kit

Siemens Healthcare Diagnostics, Inc.

Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;

MEDLINE INDUSTRIES, LP - Northfield

Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.

Baxter Healthcare Corporation

HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J

Howmedica Osteonics Corp.

Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 R

MEDLINE INDUSTRIES, LP - Northfield

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040

TELEFLEX LLC

8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205

Intuitive Surgical, Inc.

Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cl

Boston Scientific Corporation

GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05

DeRoyal Industries Inc

Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve,

Cardinal Health 200, LLC

Endo-Model Replacement Plateau; Item Number: 15-0027/12;

Waldemar Link GmbH & Co. KG (Mfg Site)

Baxter Mobile column TruSystem 7500, Product Code 1717023

Baxter Healthcare Corporation

Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa

B Braun Medical Inc

Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR

MEDLINE INDUSTRIES, LP - Northfield

SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512

Synthes (USA) Products LLC

Puritan Bennett 980 Series Ventilator, 980X1PLDIPC

Covidien Llc

BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and autho

CareFusion 303, Inc.

Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B

Medline Industries, LP