Medical Device Recalls

Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.

Orascoptic Surgical Acuity

Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A

Karl Storz Endoscopy

MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE134

MEDLINE INDUSTRIES, LP - Northfield

Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085

Omega Medical Imaging, Inc.

stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery

Stryker Corporation

Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surg

American Surgical Company, LLC

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY

MEDLINE INDUSTRIES, LP - Northfield

HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e)

C.R. Bard Inc

Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Ane

Baxter Healthcare Corporation

Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R

Smiths Medical Asd Inc

HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray

Stradis Medical, LLC dba Stradis Healthcare

L10-4LAP Transducer Probe

Philips Ultrasound, Inc

Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Versi

MEDLINE INDUSTRIES, LP - Northfield

Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA

Wilson-Cook Medical Inc.

BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software

CareFusion 303, Inc.

ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

Elekta, Inc.

Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult,

Nihon Kohden America Inc

ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Tap

Abiomed, Inc.

Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL cholesterol in human se

Siemens Healthcare Diagnostics, Inc.

HAND PACK-Procedure Kit Catalog Number: WEHD16C

American Contract Systems Inc

CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.

Wright Medical Technology, Inc.

Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K1

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,

MEDLINE INDUSTRIES, LP - Northfield

Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.

Philips Medical Systems (Cleveland) Inc

Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Mozarc Medical US LLC

ActiveAid 922, Shower/Commode Chair

Altimate Medical, Inc.

High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123

Percussionaire Corporation

Velys Enabling Tech Robotic-Assist Station REF: 451611001

Medos International Sarl

Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN

Medline Industries, LP