Medline FCE1232RSRNRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10080196313877), received between Jul 1, 2021 and Sep 16, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Material Deformation

  It was reported that "RAILS WERE DELIVERED DAMAGED" and "the rail will not move."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793160 ↗
• MalfunctionSep 14, 2026Material Deformation; Physical Resistance/Sticking

  It was reported that "Rep & customer both express difficulty with moving the rail up and down" and "for installing the rail, the rail must be opened to mount it to the side of the bed."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754176 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING TRANSFERRED FROM THE WHEELCHAIR TO THE BED AND WHEN THE STAFF ATTEMPTED TO TRANSFER THE PATIENT THE RAIL OF THE BED CAUGHT ON THE PATIENTS LEFT LOWER LEG RESULTING IN A 14 CM LONG LACERATION REQUIRING SUTURES.

  Patient problems: Laceration(s)

  MAUDE report 12104062 ↗