- Safety alert
Medical device recalls
A device recall may call for a repair, a software update or new instructions. Identify your exact device, then read what FDA and the manufacturer say to do next.
- Indexed notices
- 64
- Primary sources
- FDA
What this category covers
Glucose monitors, CPAP devices, Test kits, Implants. Home health equipment, test kits and implants, including FDA recalls and early safety alerts.
Check with the official agency or read the product identification guide. Source coverage explains which notices are indexed and when each source was imported.
Recalls & safety alerts
64 indexed notices. Always compare with the current official notice.
FDA
Olympus: MAJ-891 endoscope accessory
Risk of device contamination that may result from improper reprocessing.
- Safety alert
FDA
Max Mobility/Permobil: Speed Control Dial Component
Due to potential safety and performance concerns.
- Recall
- Recall
FDA
Philips Respironics: Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators
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 occur, there is a possibility of inaccurate flow measurements affecting therapy.
- Safety alert
FDA
Bivona: Bivona® Aire-Cuf®, TTS™, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tube(s) and Bivona Aire-Cuf®, TTS™, Cuffless FlexTend™, TTS™ FlexTend™ Adult Tracheostomy Tube(s)
The securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
- Safety alert
FDA
Tandem: T:Connect Mobile App for iOS Devices
Rapid Depletion of a User’s t:slim X2 Insulin Pump Battery
- Recall
FDA
Breas: Vivo 45 LS (US Version) Ventilator
Potential for short term elevated levels of formaldehyde exposure
- Safety alert
Read the product identification guide
Official checking resources
- FDA device recalls & early alerts — Serious device recalls, early alerts and updates.
- FDA device recall database — Search the broader database by device, company or recall information.
Data sources & coverage
Official sources may have newer notices or a broader history. See all sources and coverage.