Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX500. Product Number: 866064.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX450. Product Number: 866062.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX400. Product Number: 866060.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX100. Product Number: 867033.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue Multi-Measurement Module X3. Product Number: 867030.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue Multi Measurement Server X2. Product Number: M3002A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue MP90. Product Number: M8010A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue MP80. Product Number: M8008A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue MP70. Product Number: M8007A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue MP60. Product Number: M8005A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue MP50. Product Number: M8004A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue MP40. Product Number: M8003A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue MP30. Product Number: M8002A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue MP20. Product Number: M8001A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue MP5. Product Number: M8105A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue MP2. Product Number: M8102A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DeviceFresenius Kabi USA, LLCClass IIIvenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
- 2025-12-10FDA-DeviceBaxter Healthcare CorporationClass IIWelch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
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.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass II8 in 1 STI Test Kit
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass II3 in 1 STI Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass II2 in 1 Trichomonas / Gardnerella Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IISerotonin Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIPollen Allergy Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIPet Allergy Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIMelatonin Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIIron Deficiency Test (ferritin)
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIIodine Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIHeavy Metals Test
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIFood Intolerance Test Small
Distribution without premarket approval/clearance.
- 2025-12-10FDA-DeviceGET TESTED INTERNATIONAL ABClass IIFood Intolerance Test Medium
Distribution without premarket approval/clearance.
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