July 9, 2025Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Cardiology Hemodynamics Software
Hazard: Due to complaints, software update may cause software to unexpectedly shutdown.
July 9, 2025Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Cardiology Hemo Software
Hazard: Due to complaints, software update may cause software to unexpectedly shutdown.
July 9, 2025Medical DevicesFDA
HemoCue AB recalls The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma con
Hazard: Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.
July 9, 2025Medical DevicesFDA
CORIN MEDICAL, LTD. recalls Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-5015
Hazard: Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips XL14-3 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips X8-2t Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips X7-2t Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips X6-1 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips X5-1 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips VL13-5 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips V6-2 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips S8-3t Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips S7-3t Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips S7-2 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips S5-1 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips L9-3 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips L8-4 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips L12-4 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips L12-3 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips eL18-4 EMT Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips eL18-4 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips C9-5EC Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips C5-2 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips C5-1 Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
Philips Ultrasound, Inc recalls Philips 3D9-3v Transducer.
Hazard: Ultrasound transducer devices were refurbished beyond their useful life.
July 9, 2025Medical DevicesFDA
LUMITHERA INC recalls Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Pro
Hazard: U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.
July 9, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK
Hazard: Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
July 9, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX
Hazard: Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
July 9, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAW
Hazard: Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
July 9, 2025Medical DevicesFDA
Onkos Surgical, Inc. recalls My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Sho
Hazard: Required inspections were not performed on finished product prior to release and distribution.