NOA Medical Industries, Inc. 1055050GRYRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817492012745), received between Jan 7, 2025 and Jan 7, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 5, 2024Class IIOpen, Classified

   Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.

   Z-0838-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2025Mechanical Problem; Mechanical Problem

  (B)(4), CUSTOMER REPORTED ISSUE WITH THE RIGHT-SIDE HEAD SIDE RAIL. WHEN PRESSING THE RELEASE BUTTON, THE SIDE RAIL GETS STUCK. THERE IS A METAL PIECE THAT NEEDS TO RETRACT WHEN PUSHING THE RED BUTTON, BUT IT DOES NOT RETRACT COMPLETELY, AND THAT IS WHY THE SIDERAIL GETS STUCK. DEVICE WAS NOT RETURNED FOR INVESTIGATION. SIDE RAIL IS PART OF THE BED PACKAGE. THERE ARE NO PROBLEMS WITH THE BED ITSELF. REPORT IS BEING FILED AFTER THE 30 DAY TIMEFRAME DUE TO CONFUSION REGARDING THE FILING OF MDRS WITH LITTLE INFORMATION. WE ARE REPORTING THE INFORMATION REASONABLY KNOWN TO US OUT OF AN ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092230 ↗
• MalfunctionJan 7, 2025Mechanical Problem; Mechanical Problem

  (B)(4), ON TUE, DEC 5, 2023 AT 9:41AM WE RECEIVED AN EMAIL ALLEGING THAT THE RED BUTTON ON THE SIDE RAIL THAT RELEASES THE RAIL TO DROP DOWN WAS STUCK INSIDE AND DOESN'T POP OUT AS IT SHOULD TO LOCK THE RAIL IN PLACE. THE RAIL ISN'T LOCKING INTO PLACE, WHICH ALLOWED HIM TO FALL OUT OF HIS BED DUE TO THE RAIL DROPPING FROM THE UPRIGHT POSITION. FORTUNATELY, HE IS OKAY BUT THE RAIL IS NOT. INCIDENT WAS REPORTED FROM A USER VIA A DISTRIBUTOR, NO OTHER INFORMATION WAS PROVIDED. WE SENT A REPLACEMENT WITH A RETURN LABEL SO THE DEVICE COULD RETURN FOR INVESTIGATION. WE REACHED OUT AGAIN LATER WHEN THE PART HAD NOT RETURNED OFFERING TO SEND ANOTHER RETURN LABEL BUT NEVER HEARD BACK FROM THE CUSTOMER. WE COULD NOT DETERMINE THAT A MALFUNCTION OCCURED. REPORT IS BEING FILED AFTER THE 30 DAY TIMELINE DUE TO CONFUSION OVER THE FILING OF MDRS WITH LITTLE INFORMATION. WE ARE REPORTING WITH THE INFORMATION REASONABLY KNOWN TO US OUT OF AN ABUNDANCE OF CAUTION. SIDE RAIL IS PART OF THE BED PACKAGE. THERE ARE NO PROBLEMS ASSOCIATED WITH THE BED ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091763 ↗