SARA FLEX HEB0000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05056097354941), received between Mar 4, 2022 and Jun 3, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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.

• InjuryJun 3, 2026Insufficient Device Problem Information

  A RESIDENT LOST BALANCE DURING A TRANSFER FROM BED TO AN ELECTRIC WHEELCHAIR USING ARJO SARA FLEX LIFT AND ARJO SLING AFTER HER LEFT KNEE SHIFTED WITHIN THE CALF SUPPORT DURING THE STANDING PHASE. THE CAREGIVER WAS ABLE TO CATCH THE RESIDENT AND GUIDE HER SAFELY TO THE GROUND; HOWEVER, THE LEGS REMAINED SECURED BEHIND THE CALVES IN THE SUPPORT, RESULTING IN PRESSURE BEING APPLIED TO THE RESIDENT¿S KNEE. THE RESIDENT SUSTAINED A KNEE FRACTURE THAT REQUIRED SURGERY. THE DEVICE INSPECTION DID NOT REVEAL ANY PRODUCT MALFUNCTION. THE DEVICE OPERATED CORRECTLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 25370807 ↗
• InjuryMar 4, 2022Use of Device Problem; Use of Device Problem

  ARJO RECEIVED A NOTIFICATION REGARDING THE EVENT WITH A SARA FLEX ACTIVE LIFT. IT WAS REPORTED THAT A RESIDENT OF THE NURSING HOME, WHO IS SUFFERING FROM SEVERE OSTEOPOROSIS, WAS BEING TRANSPORTED IN A STANDING AID FROM THE BED TO THE BATHROOM. FOLLOWING THE INFORMATION RECEIVED THE RESIDENT WAS HELPED TO STAND UP WITH THE STANDING AID AND IN THIS MOMENT BROKE HER ANKLE. THE RESIDENT WAS NOT ABLE TO STAY UP AND SINKS IN THE DEVICE. SHE COULD NOT HOLD THE FEET ON THE PLATFORM, BUT THE SAFETY BELT USED TO KEEP THE FEET CLOSE TO THE FOOTREST HAS BEEN REMOVED. THIS CAUSED THAT THE PERSON ROTATED IN THE DEVICE. THIS CONTRIBUTED TO A FRACTURE OF BOTH FEMURS. IT WAS REPORTED THAT THE RESIDENT IS STILL IN HOSPITAL.

  Patient problems: Multiple Fractures

  MAUDE report 13666419 ↗
• InjuryMar 4, 2022Use of Device Problem; Use of Device Problem

  ARJO RECEIVED A NOTIFICATION REGARDING THE EVENT WITH A SARA FLEX ACTIVE LIFT. IT WAS REPORTED THAT A RESIDENT OF THE NURSING HOME, WHO IS SUFFERING FROM SEVERE OSTEOPOROSIS, WAS BEING TRANSPORTED IN A STANDING AID FROM THE BED TO THE BATHROOM. FOLLOWING THE INFORMATION RECEIVED THE RESIDENT WAS HELPED TO STAND UP WITH THE STANDING AID AND IN THIS MOMENT BROKE HER ANKLE. THE RESIDENT WAS NOT ABLE TO STAY UP AND SINKS IN THE DEVICE. SHE COULD NOT HOLD THE FEET ON THE PLATFORM, BUT THE SAFETY BELT USED TO KEEP THE FEET CLOSE TO THE FOOTREST HAS BEEN REMOVED. THIS CAUSED THAT THE PERSON ROTATED IN THE DEVICE. THIS CONTRIBUTED TO A FRACTURE OF BOTH FEMURS. IT WAS REPORTED THAT THE RESIDENT IS STILL IN HOSPITAL.

  Patient problems: Multiple Fractures

  MAUDE report 13666279 ↗