Create a Report

Please provide report title

Please provide location

Please provide details

Make my report private

Alert regulators Alert business or product owner Get notifications for my case

Get alerts and updates for your case!

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

Please provide email or phone

Phone Number

Please provide email or phone

Show my report on homepage

We do not show your email or contact info

Skip this step

I agree to Terms & Conditions

Please accept our Terms & Conditions

Email or SMS copy of report

Enter below to get emailed a copy of your report, or sms a link to your report

Please provide email or phone

Phone number

Please provide email or phone

I agree to Terms & Conditions

Please accept our Terms & Conditions

Safety Reports: Medical Devices

Updated: March 10, 2025 6:02 PM

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

2 weeks ago •source fda.gov • details

Recall notice

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

Portex Intubation Endotracheal Tubes recalled due to Smaller Diameter of Device photo #1

Helpful
Follow
Add my report
Share
- Copy link

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

1 month ago •source fda.gov • details

Recall notice

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

#medicaldevices #recall #unitedstates

Olympus MAJ-891 endoscope accessory recalled due to risk of contamination photo #1

Helpful
Follow
Add my report
Share
- Copy link

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

2 months ago •source fda.gov • details

Recall notice

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

Max Mobility/Permobil Speed Control Dial Component recalled due to unresponsive motor photo #1

Helpful
Follow
Add my report
Share
- Copy link

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

5 months ago •source fda.gov • details

Recall notice

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

#medicaldevices #recall #unitedstates

Medtronic MiniMed series insulin pumps - recalled due to Defect photo #1

Helpful
Follow
Add my report
Share
- Copy link

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

5 months ago •source fda.gov • details

Recall notice

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

#medicaldevices #recall #unitedstates

Philips Respironics Trilogy Evo Ventilators- recalled due to inaccurate flow measurements photo #1

4

Helpful
Follow
Add my report
Share
- Copy link

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

6 months ago •source fda.gov • details

Recall notice

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

Pediatric and Adult Tracheostomy products - recalled due to manufacturing defect photo #1

4

Helpful
Follow
Add my report
Share
- Copy link

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

7 months ago •source fda.gov • details

Recall notice

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

#medicaldevices #unitedstates

Tandem iOS Mobile App - recalled due to Insulin Pump Battery Issue photo #1

312

Helpful
Follow
Add my report
Share
- Copy link

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

7 months ago •source fda.gov • details

Recall notice

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

#medicaldevices #recall #unitedstates

Breas Vivo 45 LS Ventilator - recalled due to formaldehyde exposure photo #1

312

Helpful
Follow
Add my report
Share
- Copy link

Abbott FreeStyle Libre® 3 sensors - recalled due to Sensors incorrect readings, USA

7 months ago •source fda.gov • details

Recall notice

Abbott has initiated a voluntary medical device correction for a small number of FreeStyle Libre® 3 sensors due to sensors may provide incorrect high glucose readings. The product was distributed in the United States during the first half of May 2024.

The FreeStyle Libre 3 system includes… See more

#medicaldevices #recall #unitedstates

Abbott FreeStyle Libre® 3 sensors - recalled due to Sensors incorrect readings photo #1

312

Helpful
Follow
Add my report
Share
- Copy link

Volara System Single-Patient Use Circuit and Blue Ventilator Adapter recalled for Handset Plug Issue, USA

8 months ago •source fda.gov • details

Recall notice

Baxter International Inc. issued an Urgent Medical Device Recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly. The recall is due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. The impacted accessories… See more

#medicaldevices #recall #unitedstates

Volara System Single-Patient Use Circuit and Blue Ventilator Adapter recalled for Handset Plug Issue photo #1

312

Helpful
Follow
Add my report
Share
- Copy link

Create a Report

Get alerts and updates for your case!

Add photos or video

Email or SMS copy of report

Thank you for your report!

Safety Reports: Medical Devices

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

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

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

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

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

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

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

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

Abbott FreeStyle Libre® 3 sensors - recalled due to Sensors incorrect readings, USA

Volara System Single-Patient Use Circuit and Blue Ventilator Adapter recalled for Handset Plug Issue, USA

I have a concern about this report:

Resolve my concern fast!

Thanks for your feedback!

Notify me when my concern is resolved

Thanks for your feedback!