Medical Device Recalls

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20

MEDLINE INDUSTRIES, LP - Northfield

CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through

Maquet Medical Systems USA

RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX

Bolton Medical Inc.

EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only

Natus Medical Incorporated

Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I

MEDLINE INDUSTRIES, LP - Northfield

Baxter Operating Table TruSystem 7000 V, Product code REF 1841050

Baxter Healthcare Corporation

BORN ON ARRIVAL KIT , Model No LLBN11B

American Contract Systems Inc

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item C

Smiths Medical ASD Inc.

Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)

Becton Dickinson & Company

MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) OR

MEDLINE INDUSTRIES, LP - Northfield

Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used

Medtronic Neurosurgery

Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only

Abbott Medical

DREAMTOME 49-30MM/260CM Material Number: M00584010

Boston Scientific Corporation

Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010

Cardinal Health

Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitor

Draeger Medical Systems, Inc.

a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number:

Mckesson Medical-Surgical Inc. Corporate Office

Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;

Abiomed, Inc.

Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-V

Aizu Olympus Co., Ltd.

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-

Olympus Corporation of the Americas

Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.

Waldemar Link GmbH & Co. KG (Mfg Site)

NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platfor

Medacta Usa Inc

Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human

Siemens Healthcare Diagnostics, Inc.

ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators

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

t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim

Tandem Diabetes Care Inc

ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabi

Zimmer, Inc.

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

Smiths Medical ASD, Inc.

AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324

MICROVENTION INC.

OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component

OmniLife Science

GYROSCAN T5, Magnetic Resonance System.

Philips North America Llc

Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

Maquet Cardiovascular, LLC