Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class III · 1+ years ago
Philips Ultrasound, Inc C6-2 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 1+ years ago
Medline Kits containing BD SureStep Foley Tray Systems recall: Kits contain SureStep Foley Tray Systems recalled by BD that include
Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used…
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Class II · 1+ years ago
Orascoptic Superior Visualization Dragonfly Essentials Kit recall: Due to complaints, loupe nose pads containing nickel may cause an allergic
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
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Class II · 1+ years ago
American Contract Systems, Medical Procedure kits and trays labeled recall: During an internal investigation, ACS determined that the rationale
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some…
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Class III · 1+ years ago
Philips Ultrasound, Inc Transducer L12-5 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 1+ years ago
Tandem Diabetes Care t:slim X2 insulin pumps recall: Potential speaker-related issue that can trigger an error resulting
Potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery
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Elevated risk · 1+ years ago
Alaris™ and BD Alaris™ Pump Modules recall: May have been serviced with previously recalled bezel kit assemblies
May have been serviced with previously recalled bezel kit assemblies
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Elevated risk · 1+ years ago
Newport™ HT70 and HT70 Plus ventilators and certain related service recall: Device & Drug Safety - Potential Defect
Device & Drug Safety - Potential Defect
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Elevated risk · 1+ years ago
Q’Apel Medical 072 Aspiration System recall: Distal Tip Design outside scope of 510k clearance
Distal Tip Design outside scope of 510k clearance
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Elevated risk · 1+ years ago
enVista Aspire™, enVista Envy™ and Certain enVista® Monofocal recall: Increased frequency of reports of toxic anterior segment syndrome
Increased frequency of reports of toxic anterior segment syndrome
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Elevated risk · 1+ years ago
Portex Intubation Oral/Nasal Endotracheal Tubes recall: Diameter of Device Smaller than Expected
Diameter of Device Smaller than Expected
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Elevated risk · 1+ years ago
Olympus MAJ-891 endoscope accessory recall: Risk of device contamination that may result from improper reprocessing
Risk of device contamination that may result from improper reprocessing.
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Class I · 1+ years ago
Max Mobility/Permobil Speed Control Dial Component recall: Due to potential safety and performance concerns
Due to potential safety and performance concerns
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Elevated risk · 2+ years ago
Philips Respironics Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal recall: The use of in-line nebulizers placed in certain locations may lead to aerosol
The use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this…
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Elevated risk · 2+ years ago
Medtronic MiniMed™ 600 series or 700 series insulin pumps recall: Device & Drug Safety - Defect
Device & Drug Safety - Defect
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Elevated risk · 2+ years ago
Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric recall: The securement flange of specific lots of the Bivona Neonatal/Pediatric
The securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
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Elevated risk · 2+ years ago
Tandem T:Connect Mobile App for iOS Devices recall: Rapid Depletion of a User’s t:slim X2 Insulin Pump Battery
Rapid Depletion of a User’s t:slim X2 Insulin Pump Battery
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Elevated risk · 2+ years ago
Breas Vivo 45 LS Ventilator recall: Potential for short term elevated levels of formaldehyde exposure
Potential for short term elevated levels of formaldehyde exposure
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Elevated risk · 2+ years ago
Abbott FreeStyle Libre® 3 sensors recall: Sensors may provide incorrect high glucose readings
Sensors may provide incorrect high glucose readings
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Elevated risk · 2+ years ago
Volara system single-patient use circuit and blue ventilator adapter recall: Reports of the handset plug disconnecting from the nebulizer port on the blue
Reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter
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Highest risk · 2+ years ago
Baxter Life2000 Ventilator with an attached battery charger dongle recall: Potential Battery Charger Dongle Damage
Potential Battery Charger Dongle Damage
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Elevated risk · 2+ years ago
Medline SubG Endotracheal Tubes with Subglottic Suction and kits that contain recall: The inflation tube and other device components have become detached and/or
The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, loss of pressure…
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Highest risk · 2+ years ago
Ethicon Megadyne Mega Soft Pediatric Patient Return Electrode recall: Reports of patient burn injuries
Reports of patient burn injuries
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Elevated risk · 2+ years ago
Medline and Centurion Convenience kits recall: The potential for a lack of sterility
The potential for a lack of sterility