SARA PLUS HEP1001-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05055982787451), received between Jun 25, 2025 and Feb 11, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 11, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A TOILETING PROCEDURE USING SARA PLUS, THE PATIENT FELL AND HIT HIS CHIN AND TOE. AS A RESULT, THE PATIENT EXPERIENCED IMMEDIATE PAIN IN THE CHIN, FOLLOWED BY TOE PAIN 10¿15 MINUTES LATER. THE PATIENT WAS EVALUATED IN THE EMERGENCY ROOM, WHERE X-RAYS AND ALL OTHER IMAGING WERE NEGATIVE. NO HOSPITALIZATION WAS REQUIRED. ACCORDING TO THE FACILITY, THE PATIENT INITIALLY FELT UNCOMFORTABLE WHILE BEING LIFTED AND WAS LOWERED BACK DOWN. AFTER REPOSITIONING, A SECOND LIFTING ATTEMPT WAS MADE, DURING WHICH THE PATIENT WAS UNABLE TO SUPPORT HIMSELF. THE CAREGIVER PRESSED THE "DOWN" BUTTON, BUT THE LIFT STOPPED FUNCTIONING. THE STAFF THEN ATTEMPTED TO REPOSITION THE PATIENT¿S FEET (THE PATIENT IS PARTIALLY PARALYZED DUE TO A SPINAL CORD INJURY). THE FACILITY STAFF DECLINED TO PROVIDE ANY FURTHER CLARIFICATION REGARDING THE INCIDENT; THEREFORE, WE ARE UNABLE TO VERIFY THE STATEMENTS PROVIDED OR DETERMINE THE EXACT CIRCUMSTANCES OF THE FALL OR AT WHAT MOMENT IT OCCURRED.

  Patient problems: Fall; Pain

  MAUDE report 24313229 ↗
• InjuryJul 25, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT WHILE USING THE SARA PLUS FLOOR LIFT, THE LIFT STALLED, CAUSING THE RESIDENT'S LEGS TO BUCKLE AND THE RESIDENT TO HANG SUSPENDED BY THE SAFETY STRAP. THE WEIGHT OF THE DEVICE PRESSED DOWN ON THE RIGHT KNEE. THE LIFT SHIFTED AND ROLLED OVER THE RESIDENT'S FOOT AS THE LEGS SLIPPED UNDERNEATH. DUE TO THE RESIDENT'S BODY POSITION, THE CAREGIVER COULD NOT ACCESS THE SAFETY RELEASE BUTTON. THE EVENT RESULTED IN A CUT ON A DIABETIC FOOT AND REDNESS ON THE RESIDENT'S KNEE. THE RESIDENT'S OUTCOME WAS ASSESSED BY THE CLINICAL SPECIALIST AS A SERIOUS INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Movement Disorder

  MAUDE report 22606876 ↗
• InjuryJun 25, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT WHILE USING THE SARA PLUS FLOOR LIFT, THE LIFT STALLED, CAUSING THE RESIDENT¿S LEGS TO BUCKLE AND THE RESIDENT TO HANG SUSPENDED BY THE SAFETY STRAP. THE WEIGHT OF THE DEVICE PRESSED DOWN ON THE RIGHT KNEE. THE LIFT SHIFTED AND ROLLED OVER THE RESIDENT¿S FOOT AS THE LEGS SLIPPED UNDERNEATH. DUE TO THE RESIDENT¿S BODY POSITION, THE CAREGIVER COULD NOT ACCESS THE SAFETY RELEASE BUTTON. THERE IS NO INDICATION THAT A SERIOUS INJURY OCCURRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Movement Disorder

  MAUDE report 22331064 ↗