Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 11 months ago
Get Tested International Ab 8 in 1 STI Test Kit recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Gut Microbiome Test Small recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Philips North America Llc IntelliVue Patient Monitor MX850. Product Number: 866470 recall: Potential issue where the IntelliVue monitors did not alarm
Potential issue where the IntelliVue monitors did not alarm.
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Class II · 11 months ago
Get Tested International Ab PSA Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Paragon 28, Inc. Phantom recall: Fibula nail system intended for use in fixation of fibular fractures
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so…
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Class II · 11 months ago
Get Tested International Ab Lactose Intolerance Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Philips North America Llc IntelliVue Patient Monitor MX500. Product Number: 866064 recall: Potential issue where the IntelliVue monitors did not alarm
Potential issue where the IntelliVue monitors did not alarm.
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Class II · 11 months ago
Get Tested International Ab Urinary Tract Infection Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Philips North America Llc CT 5300 recall: If the screws of tube heat exchanger on the rotating scanner
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make…
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Class II · 11 months ago
Philips North America Llc IntelliVue Patient Monitor MX700. Product Number: 865241 recall: Potential issue where the IntelliVue monitors did not alarm
Potential issue where the IntelliVue monitors did not alarm.
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Class II · 11 months ago
Get Tested International Ab Pet Allergy Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Gut Microbiome Test XL recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Alcohol Test Saliva recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System , Large Volume Pump recall: Downstream Occlusion alarms may occur during procedures using low flow
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
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Class II · 11 months ago
Get Tested International Ab Pollen Allergy Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Baxter Healthcare Corporation Welch Allyn INF BAG, Thigh 1-Tube, Model/ recall: Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure
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…
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Class II · 11 months ago
Get Tested International Ab Neurotransmitters Plus recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Adrenal Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Parasite Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Mycoplasma test, IgG and IgM recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Sperm Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Philips Ultrasound, LLC Lumify Diagnostic recall: Ultrasound system compatibility issues with Apple devices running iOS 18
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
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Class II · 11 months ago
Get Tested International Ab HPV Antigen Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Illegally Marketed recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.