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Safety Reports: Medical Devices

Updated:

Real Time Reports

Recall notice

####072 Aspiration System recalled due to Distal Tip Design outside scope of 510k clearance####, USA

10 months ago •source fda.gov • details

The U.S. Food and Drug Administration ("FDA" or "the agency"), classified Q'Apel Medical, Inc.'s ("Q'Apel" or "the company") voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name "Hippo", which includes "Cheetah"; collectively, the "product") as Class I. The product was… See more

#medicaldevices #unitedstates

Recalls 072 Aspiration System recalled due to Distal Tip Design outside scope of 510k clearance The U.S. Foo... photo #1
  Comments Comment

Recall notice

Max Mobility/Permobil Speed Control Dial Component recalled due to safety concerns, USA

11 months ago •source fda.gov • details

Max Mobility/Permobil has expanded the recall of the Speed Control Dial, a wired control option for the SmartDrive MX2+ Power Assist Device, due to safety and performance concerns. The recall was originally initiated on December 20, 2024, and has been expanded to address recalled products that may… See more

#medicaldevices #unitedstates

Recalls Max Mobility/Permobil Speed Control Dial Component recalled due to safety concerns Max Mobility/Perm... photo #1
  Comments Comment

Recall notice

Portex Intubation Endotracheal Tubes recalled due to Smaller Diameter of Device, USA

1 year ago •source fda.gov • details

Smiths Medical has issued an Urgent Medical Device Correction to notify affected global customers of a potential issue with the 2.0, 2.5, 3.0 and 3.5 mm sizes of Intubation ORAL/NASAL Endotracheal Tube products being smaller than expected. To date, Smiths Medical has received eight (8) reports of… See more

#medicaldevices #unitedstates

Recalls Portex Intubation Endotracheal Tubes recalled due to Smaller Diameter of Device Smiths Medical has i... photo #1
  Comments Comment

Recall notice

Olympus MAJ-891 endoscope accessory recalled due to risk of contamination, USA

1 year ago •source fda.gov • details

Olympus Corporation has announced a voluntary Advisory Notice for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 related to the risk of device contamination that may result from improper reprocessing of the MAJ-891 accessory. The MAJ-891 is an endoscope accessory attached to the instrument channel port of certain… See more

#recall #medicaldevices #unitedstates

Recalls Olympus MAJ-891 endoscope accessory recalled due to risk of contamination Olympus Corporation has an... photo #1
  Comments Comment

Recall notice

Max Mobility/Permobil Speed Control Dial Component recalled due to unresponsive motor, USA

1 year ago •source fda.gov • details

Max Mobility/Permobil has initiated a nationwide recall of the Speed Control Dial component used with the SmartDrive MX2+ Power Assist Device due to potential safety and performance concerns. Customers were notified by email on December 20, 2024. Max Mobility/Permobil has identified a material change with the printed… See more

#medicaldevices #unitedstates

Recalls Max Mobility/Permobil Speed Control Dial Component recalled due to unresponsive motor Max Mobility/P... photo #1
  Comments Comment

Recall notice

Medtronic MiniMed series insulin pumps - recalled due to Defect, USA

1 year ago •source fda.gov • details

Medtronic plc voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump’s built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery… See more

#ketogummiesscam #scam #medicaldevices #recall #unitedstates

Recalls Medtronic MiniMed series insulin pumps - recalled due to Defect Medtronic plc voluntarily issued a f... photo #1
  Comments Comment

Recall notice

Philips Respironics Trilogy Evo Ventilators- recalled due to inaccurate flow measurements, USA

1 year ago •source fda.gov • details

Philips Respironics issued a voluntary recall for Trilogy Evo Ventilators regarding the use of in-line nebulizers. The products have been distributed nationwide.

Potential hazards to patients from these conditions may include respiratory discomfort; lung injury from too much air in the lungs or change in pressure (volutrauma/barotrauma);… See more

#recall #medicaldevices #unitedstates

Recalls Philips Respironics Trilogy Evo Ventilators- recalled due to inaccurate flow measurements Philips Re... photo #1
4   Comments Comment

Recall notice

Pediatric and Adult Tracheostomy products - recalled due to manufacturing defect, USA

1 year ago •source fda.gov • details

Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, to notify affected customers of a potential issue with certain Bivona® Tracheostomy Tubes in the United States.

The customer notification sent on May 29, 2024, indicated that if the flange on the item is torn… See more

#medicaldevices #unitedstates

Recalls Pediatric and Adult Tracheostomy products - recalled due to manufacturing defect Smiths Medical issu... photo #1
4   Comments Comment

Recall notice

Tandem iOS Mobile App - recalled due to Insulin Pump Battery Issue, USA

1 year ago •source fda.gov • details

Tandem Diabetes Care, Inc. (Nasdaq: TNDM) today provided an update on the March 2024 recall of its Apple iOS t:connect mobile app in the United States relating to an issue that can cause rapid depletion of a user's t:slim X2 insulin pump battery. This battery depletion can… See more

#scam #ketogummiesscam #medicaldevices #unitedstates

Recalls Tandem iOS Mobile App - recalled due to Insulin Pump Battery Issue Tandem Diabetes Care, Inc. (Nasda... photo #1
312   Comments Comment

Recall notice

Breas Vivo 45 LS Ventilator - recalled due to formaldehyde exposure, USA

1 year ago •source fda.gov • details

Breas Medical initiated a U.S. nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing of the ventilator identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions.

Short term formaldehyde emissions may lead to adverse pulmonary or neurological effects… See more

#recall #medicaldevices #unitedstates

Recalls Breas Vivo 45 LS Ventilator - recalled due to formaldehyde exposure Breas Medical initiated a U.S. n... photo #1
312   Comments Comment

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