Handicare 547810Recalls & reported problems
Handicare USA, Inc. · Positioning Sling, Disposable 52" x 78" · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810045514659), received between Apr 15, 2026 and May 21, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Material Split, Cut or Torn
CUSTOMER REPORTED AN MDR TO FDA: "WHILE TRANSFERRING THE PATIENT FROM THE BED THAT PATIENT ARRIVED IN FROM OUTPATIENT SETTING TO BARIATRIC HOSPITAL BED USING A HOYER THAT IS APPROVED FOR 1000LBS AND A TRANSFER SHEET ALSO APPROVED FOR 1000LBS, THE TRANSFER SHEET RIPPED WHEN LIFTING THE PATIENT OVER THE BED. THE PATIENT WAS IMMEDIATELY LOWERED ONTO HIS OUTPATIENT BED AND THE MANEUVERER WAS ABORTED. THE PATIENT STATED HE WAS OKAY AND NOT INJURED. THE LIFT WAS ABOUT 4-5 INCHES ABOVE THE BED WHEN IT RIPPED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25247753 ↗MalfunctionApr 15, 2026
PER STAFF, WHILE TRANSFERRING THE PATIENT FROM THE BED THAT PATIENT ARRIVED IN FROM OUTPATIENT SETTING TO BARIATRIC HOSPITAL BED USING A HOYER THAT IS APPROVED FOR 1000LBS AND A TRANSFER SHEET ALSO APPROVED FOR 1000LBS THE TRANSFER SHEET RIPPED WHEN LIFTING THE PATIENT OVER THE BED. THE PATIENT WAS IMMEDIATELY LOWERED ONTO HIS OUTPATIENT BED AND THE MANURER WAS ABORTED. THE PATIENT STATED HE WAS OKAY AND NOT INJURED. THE LIFT WAS ABOUT 4-5 INCHES ABOVE THE BED WHEN IT RIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24888243 ↗
Other Sling, Overhead Suspension, Wheelchair devices
- Handicare 341610Handicare USA, Inc. · Sling, Overhead Suspension, Wheelchair3 reports
- Handicare 400032Handicare USA, Inc. · Sling, Overhead Suspension, Wheelchair1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.