Medical device recalls
38845 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-DeviceMicrobiologics IncClass IIKWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
- 2025-12-10FDA-DeviceAizu Olympus Co., Ltd.Class IIOlympus OER-Mini
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- 2025-12-10FDA-DeviceAizu Olympus Co., Ltd.Class IIOlympus OER-Pro
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- 2025-12-10FDA-DeviceAizu Olympus Co., Ltd.Class IIOlympus OER-Elite
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- 2025-12-10FDA-DeviceParagon 28, Inc.Class IIPhantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX850. Product Number: 866470.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX800. Product Number: 865240.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX750. Product Number: 866471.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX700. Product Number: 865241.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX600. Product Number: 865242.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10FDA-DevicePhilips North America LlcClass IIIntelliVue Patient Monitor MX550. Product Number: 866066.
Potential issue where the IntelliVue monitors did not alarm.
- 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.
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