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.
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.
64 indexed notices. Always compare with the current official notice.
As currently written, the Owner’s Booklets/System Instructions for Use fails to emphasize that users must seek medical attention immediately if they receive an E-5 error code and are experiencing symptoms of high glucose.
Internal testing determined that some sensors may provide incorrect low glucose readings.
Potential Salmonella contamination, presence of rodent and avian contamination and insanitary conditions during the storage process.
PolyLoop device may fail to detach as expected and become anchored to patient anatomy
Potential for defective LCD displays that can affect product performance
Read the product identification guide
Official sources may have newer notices or a broader history. See all sources and coverage.