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 Diabetes HbA1c 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 MP40. Product Number: M8003A 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 D-Dimer 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 Intestinal Worms 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 MX100. Product Number: 867033 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
Philips North America Llc IntelliVue MP80. Product Number: M8008A 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 SIBO 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 MP50. Product Number: M8004A 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 Trichomonas Vaginalis 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 Fructose 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 Incisive CT 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
Get Tested International Ab Heavy Metals 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 Peptic Ulcer 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 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 Food Sensitivity 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 Mycotoxin Panel Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class I · 11 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System, LVP Primary Administration Set recall: Incorrect assembly of specific lot of LVP Primary Administration Set
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
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Class II · 11 months ago
Get Tested International Ab Food Sensitivity 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 MP2. Product Number: M8102A 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
Siemens Medical Solutions USA, Inc Mammomat Fusion recall: There were instances where the operator table was sold together
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for…
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Class II · 11 months ago
Microbiologics Inc Kwik-Stik, Quality control kit for culture media recall: Some products packaged for lot 818-111-7 may have been packaged in pouches
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
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Class II · 11 months ago
Get Tested International Ab Food Intolerance Test Medium recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.
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Class II · 11 months ago
Siemens Medical Solutions USA, Inc Mammomat Inspiration recall: There were instances where the operator table was sold together
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for…
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Class II · 11 months ago
Get Tested International Ab Akkermansia Test recall: Distribution without premarket approval/clearance
Distribution without premarket approval/clearance.