Medical Device Recalls

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001658;

Beaver Visitec International, Inc.

Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Produc

DJO, LLC

MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.

MEDLINE INDUSTRIES, LP - Northfield

DeRoyal PACEMAKER ICD PACK, REF 89-10216.03

DeRoyal Industries Inc

GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M116

Wipro GE Healthcare Private Ltd.

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 01108

Bard Access Systems, Inc.

KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L

Microbiologics Inc

PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made s

B Braun Medical Inc

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;

Boston Scientific Corporation

SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510

Howmedica Osteonics Corp.

IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500

Philips North America

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYS

American Contract Systems Inc

OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF

Ossur Americas

Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue R

Flower Orthopedics Corporation

Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US; the system utilizes an int

Boston Scientific Corporation

Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ85197A DYNJT4007

Medline Industries, LP

Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19

TECHNO-PATH MANUFACTURING LTD.

AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO a

Siemens Medical Solutions USA, Inc

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64

MEDLINE INDUSTRIES, LP - Northfield

ADVANTA VXT, 6X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

Atrium Medical Corporation

GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part

GE Healthcare, LLC

ADVANTA VXT, 5X40, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft

Atrium Medical Corporation

Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vascu

BALT USA, LLC

SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

Datascope Corp.

OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60

Olympus Corporation of the Americas

Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170

MEDLINE INDUSTRIES, LP - Northfield

Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA;

Bausch & Lomb Surgical, Inc.

STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612

Diagnostica Stago, Inc.

Atlan A350. Model Number: 8211500. anesthesia workstation

Draeger, Inc.