Medical Device Recalls

Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hystero

CooperSurgical, Inc.

GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112;

GRAPHENANO DENTAL SL

Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small O

GE Medical Systems, LLC

Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Mod

Alcon Research LLC

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, frac

Waldemar Link GmbH & Co. KG (Mfg Site)

Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteros

WOM World Of Medicine AG

Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming

Stryker Corporation

COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part

Cook Incorporated

BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligamen

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04

Merit Medical Systems, Inc.

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

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

Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,

Philips Ultrasound Inc