Medical Device Recalls

Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog N

Cardinal Health 200, LLC

Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automa

Olympus Corporation of the Americas

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version

ZOLL Medical Corporation

Model No. BF-XP190, EVIS EXERA III Bronchovideoscope

Shirakawa Olympus Co., Ltd.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002000;

Beaver Visitec International, Inc.

Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

GE Healthcare

HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal therma

Ethicon Endo-Surgery Inc

LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fr

Waldemar Link GmbH & Co. KG (Mfg Site)

SIGNA Architect nuclear magnetic resonance imaging system

GE Healthcare, LLC

Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic

Beckman Coulter, Inc.

First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.

First Source Inc

Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and

Cook Incorporated

Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

American Contract Systems, Inc.

Chromophare Surgical Light System , REF CH00000001

Stryker Communications

The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop leng

Implant Direct Sybron Manufacturing LLC

Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

Smiths Medical ASD Inc.

Embrace Drill Tower, Wedged (25mm)

Waldemar Link GmbH & Co. KG (Mfg Site)

Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product C

Abiomed, Inc.

BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is perf

PTW-FREIBURG

The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Baxter Healthcare Corporation

Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356

MEDLINE INDUSTRIES, LP - Northfield

NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for

Fresenius Medical Care Holdings, Inc.

PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System

VANTIVE US HEALTHCARE LLC

Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08

AVID Medical, Inc.

Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL

Stryker Corporation

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model

MEDLINE INDUSTRIES, LP - Northfield

Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400

Abbott Medical

MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System

BioMerieux SA

Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.

Medtronic Neuromodulation

Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the pr

Fresenius Medical Care Holdings, Inc.