December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX500. Product Number: 866064.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX450. Product Number: 866062.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX400. Product Number: 866060.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX100. Product Number: 867033.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Multi-Measurement Module X3. Product Number: 867030.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Multi Measurement Server X2. Product Number: M3002A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue MP90. Product Number: M8010A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue MP80. Product Number: M8008A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue MP70. Product Number: M8007A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue MP60. Product Number: M8005A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue MP50. Product Number: M8004A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue MP40. Product Number: M8003A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue MP30. Product Number: M8002A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue MP20. Product Number: M8001A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue MP5. Product Number: M8105A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue MP2. Product Number: M8102A.
Hazard: Potential issue where the IntelliVue monitors did not alarm.
December 10, 2025Medical DevicesFDA
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Hazard: Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
December 10, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn T
Hazard: Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls 8 in 1 STI Test Kit
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls 3 in 1 STI Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls 2 in 1 Trichomonas / Gardnerella Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Serotonin Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Pollen Allergy Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Pet Allergy Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Melatonin Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Iron Deficiency Test (ferritin)
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Iodine Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Heavy Metals Test
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Food Intolerance Test Small
Hazard: Distribution without premarket approval/clearance.
December 10, 2025Medical DevicesFDA
GET TESTED INTERNATIONAL AB recalls Food Intolerance Test Medium
Hazard: Distribution without premarket approval/clearance.