Allergy test Small
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
All Recalls
95,018 total recalls in our database
IntelliVue Patient Monitor MX800. Product Number: 865240.
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
GI Microbiome Profile XL
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Illegally Marketed
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
HPV Antigen Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
Sperm Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Mycoplasma test, IgG and IgM
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Parasite Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Adrenal Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Neurotransmitters Plus
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
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.
Pollen Allergy Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Fresenius Kabi USA
🏥 Medical Devices Class I - Dangerous
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Alcohol (ALC) Test Saliva
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Gut Microbiome Test XL
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Pet Allergy Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue Patient Monitor MX700. Product Number: 865241.
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Philips North America
🏥 Medical Devices Class I - Dangerous
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
Urinary Tract Infection Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.