Medical Devices

Roche Diagnostics Corp.: VetLyte ISE Fluid Pack Recalled for Defective Seam and Inaccurate Results

• Distributed nationwide
• Sold at IDEXX Laboratories, Inc.
• 86,479 units affected

Hospira Inc.: Acclaim Encore Infusion Pumps Recalled for Broken Door Assemblies

• Sold in 47 states
• Sold at Hospira, Abbott +1 more

Hospira Inc.: Medical Irrigation and Extension Sets Recalled for Compromised Sterility

• Sold in 51 states
• Sold at Hospira Inc., Medical distributors +1 more
• 2,962,342 units affected

Hospira Inc.: Acclaim Encore Infusion Pumps Recalled for Broken Door Assemblies

• Sold in 48 states
• Sold at Veterinary clinics, Medical supply distributors
• Customer reports of broken door assemblies received; specific injury counts not detailed in available data.

Hospira Inc.: Plum A+ Infusion Pumps Recalled for Reversed Volume Control Knob

• Sold in 20 states
• Sold at Authorized veterinary distributors, Direct sales from Hospira Inc.

Masimo Rad-G Pulse Oximeters Recalled for Unexpected Power Loss

• Sold in 45 states
• Sold at Authorized Medical Distributors, Direct Sales

COVETRUS NORTH AMERICA: scil SOLO Phenobarbital Test Kits Recalled for Falsely Low Results

• Sold in 5 states
• Sold at Covetrus North America

ICU Medical, Inc.: Spinning Spiros Closed Male Luers Recalled for Potential Fluid Leaks

• Sold in Arizona
• Sold at authorized distributors

Cellavision DI-60 Morphology Analyzers Recalled for Result Misattribution

• Sold in Florida
• Sold at Authorized distributors

CareFusion: NicoletOne vEEG Systems Recalled Due to Software Protocol Errors

• Sold in Florida, New Jersey, Pennsylvania

Philips Vue Motion Software Recalled for Image Sequencing Error

• Distributed nationwide
• Sold at Authorized Medical Device Distributors, Direct Sales

Medline Sterile Radiology Procedure Kits Recalled for Packaging Breach

• Sold in Minnesota
• Sold at authorized distributors

RefleXion X1 Radiotherapy System Recalled for Software Defect

• Sold in 8 states
• Sold at Reflexion Medical, Inc. (Direct to hospitals/clinics)

AVOXimeter 1000E Oximeter Recalled for Incorrect Patient Results

• Sold in Arizona

CAIRE FreeStyle Comfort Oxygen Concentrators Recalled for Battery Charging Failure

• Distributed nationwide
• Sold at Authorized medical equipment distributors, Caire, Inc.

Esaote Endocavity Ultrasonic Probes Recalled Due to Liquid Leak Risk

• Sold in North Carolina, Texas
• Sold at Direct distribution

Kendall SCD Comfort Sleeves Recalled for Software Error and Therapy Delay

• Sold in 5 states
• Sold at Cardinal Health 200, LLC

ID NOW Influenza A & B 2 Kits Recalled for Increased Invalid Test Rates

• Distributed nationwide
• Sold at authorized distributors
• 111,984 units affected

Tytek Medical Inc: Tension Pneumothorax Access Kits Recalled for Instruction and Labeling Updates

• Sold in Ohio, South Carolina, Virginia
• 465,572 units affected

GE Medical Systems, LLC: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

Ultra IABP Catheter Kits Recalled for Unapproved Claims and Use Instructions

• Sold in 4 states
• Sold at Hospitals, Medical distributors
• 24,227 units affected

Welch Allyn Spot Vision Screener VS100 Recalled for Display Flickering

• Sold in 14 states
• Sold at Authorized medical distributors, Direct sales

MICS3 Angled Sagittal Saw Attachment Recalled for Detachment Risk

• Distributed nationwide
• Sold at Hospital and surgical distributors

Leksell Gamma Knife Radiosurgery Systems Recalled for Adapter Defect

• Sold in 37 states
• Sold at Elekta, Inc. (Direct sales and clinical distribution)