FDA medical device recalls
Formal FDA enforcement reports for medical devices — implants, monitors, diagnostic tests, and hospital and home-use equipment.
2,600 recalls in the last 12 months, translated into plain English.
- 2025-12-10Paragon 28Class 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.
- 2025-12-10PhilipsClass IIIntelliVue Patient Monitor MX850. Product Number: 866470.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue Patient Monitor MX800. Product Number: 865240.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue Patient Monitor MX750. Product Number: 866471.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue Patient Monitor MX700. Product Number: 865241.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue Patient Monitor MX600. Product Number: 865242.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue Patient Monitor MX550. Product Number: 866066.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue Patient Monitor MX500. Product Number: 866064.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue Patient Monitor MX450. Product Number: 866062.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue Patient Monitor MX400. Product Number: 866060.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue Patient Monitor MX100. Product Number: 867033.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue Multi-Measurement Module X3. Product Number: 867030.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue Multi Measurement Server X2. Product Number: M3002A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue MP90. Product Number: M8010A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue MP80. Product Number: M8008A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue MP70. Product Number: M8007A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue MP60. Product Number: M8005A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue MP50. Product Number: M8004A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue MP40. Product Number: M8003A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue MP30. Product Number: M8002A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue MP20. Product Number: M8001A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue MP5. Product Number: M8105A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10PhilipsClass IIIntelliVue MP2. Product Number: M8102A.
Potential issue where the IntelliVue monitors did not alarm.
- 2025-12-10Fresenius KabiClass 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.
- 2025-12-10BaxterClass 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.
- 2025-12-10Get TestedClass II8 in 1 STI Test Kit
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass II3 in 1 STI Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass II2 in 1 Trichomonas / Gardnerella Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IISerotonin Test
Distribution without premarket approval/clearance.
- 2025-12-10Get TestedClass IIPollen Allergy Test
Distribution without premarket approval/clearance.
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