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 Ovulation 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 Allergy & Food Intolerance 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 Pregnancy 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 MX400. Product Number: 866060 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 Liver 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 Diabetes 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 Iron Deficiency 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 Herpes 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 Thyroid TSH 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 Iron Deficiency 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 Cholesterol 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 Gonorrhea test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Illumina, Inc. Reagent Kits/ containing flow cells, components of NextSeq 550Dx recall: An instrument intended for sequencing DNA libraries with in vitro diagnostic
An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow…
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Class II · 11 months ago
Get Tested International Ab Chlamydia 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 Large 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 MX600. Product Number: 865242 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 Hair Mineral Analysis 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 MP20. Product Number: M8001A 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 Organic acids 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 MP5. Product Number: M8105A 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 Drug Test Small recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Get Tested International Ab Lyme 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 Biological Age & Longevity 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 MP60. Product Number: M8005A recall: Potential issue where the IntelliVue monitors did not alarm
Potential issue where the IntelliVue monitors did not alarm.