SmartPill FGS-0505Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04260167482705), received between Aug 22, 2024 and Aug 26, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ACCORDING TO THE REPORTER, INSIDE THE 2 PACKAGES INSECTS WERE DISCOVERED. ONE PACKAGE CONTAINED 1 LARVAE ON THE BAR AND ONE PACKAGE CONTAINED A SMALL BEETLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063919 ↗
• MalfunctionAug 26, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ACCORDING TO THE REPORTER, INSIDE THE 2 PACKAGES INSECTS WERE DISCOVERED. ONE PACKAGE CONTAINED 1 LARVAE ON THE BAR AND ONE PACKAGE CONTAINED A SMALL BEETLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063876 ↗
• MalfunctionAug 26, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THERE WERE BUGS FOUND IN THE BOXES OF THE BARS. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063702 ↗
• MalfunctionAug 26, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THERE WERE BUGS FOUND IN THE BOXES OF THE BARS. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063672 ↗
• MalfunctionAug 23, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THE BAR HAD BUGS INSIDE THE PACKAGE WHEN OPENED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047981 ↗
• MalfunctionAug 22, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THERE WERE BUGS FOUND IN THE BAR. BARS WERE NOT ABLE TO USE FOR PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043282 ↗
• MalfunctionAug 22, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, PATIENT CAME IN TO HAVE A SMARTPILL AND WAS GIVEN A SMARTBAR. SHE ATE PART OF IT, AND FOUND A WORM IN IT. THE HEALTH FACILITY SAVED THE BAR, IT WAS NOT EXPIRED, AND WAS SEALED. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043280 ↗
• MalfunctionAug 22, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, THERE WERE BUGS FOUND IN THE BAR. BARS WERE NOT ABLE TO USE FOR PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042491 ↗
• MalfunctionAug 22, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, PATIENT CAME IN TO HAVE A STUDY AND WAS GIVEN A BAR. THE PATIENT ATE PART OF IT, AND FOUND A WORM IN IT. THE HEALTH FACILITY SAVED THE BAR, IT WAS NOT EXPIRED, AND WAS SEALED. THERE IS NO PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041659 ↗