Medical Device Recalls

AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.

SonarMed Inc

Hemodialysis Delivery System, Software Version 2.x.

Baxter Healthcare Corporation

Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ve

Integra LifeSciences Corp.

Intera 1.5T Achieva Nova, Magnetic Resonance System.

Philips North America Llc

CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators

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

Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO D

MEDLINE INDUSTRIES, LP - Northfield

Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resus

SunMed Holdings, LLC

***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment

Siemens Medical Solutions USA, Inc

a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, C

Onkos Surgical, Inc.

Intera 1.5T Achieva Nova-Dual Product Number: 781173;

Philips North America

(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model

Cardinal Health 200, LLC

SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain

The Metrix Company

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL P

Medline Industries, LP

Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US)

Philips Respironics, Inc.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001629;

Beaver Visitec International, Inc.

BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to

Nihon Kohden America Inc

APK2 Pressure-Sensing Wheelchair Cushions

Aquila Corporation

VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226

Biomerieux Inc

Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986

Microtek Medical, Inc.

S9-2 Transducer Probe

Philips Ultrasound, Inc

HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 2

Stradis Medical, LLC dba Stradis Healthcare

Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the l

Aesculap Implant Systems LLC

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description

Trividia Health, Inc.

Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED

Cardinal Health 200, LLC

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

MEDLINE INDUSTRIES, LP - Northfield

Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in

Synthes (USA) Products LLC

DERMARITE INDUSTRIES SafeWash Saline Saline Wound Flush SafeWash 7.1 oz. Can Sterile 0.9% Sodium Chloride Model Number:

Mckesson Medical-Surgical Inc. Corporate Office

Hanger-Bar 2P 45cm

Human Care USA, Inc.

Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

Nobel Biocare

BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;

CareFusion 303, Inc.