POSEY 2530Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190676002884), received between Nov 29, 2022 and Mar 22, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Product Quality 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2024Product Quality Problem; Product Quality Problem

  CUSTOMER REPORTING COMPLAINT ON PRODUCT # 2530. CUSTOMER STATES THAT THE STRAP MATERIAL IS TOO THIN TO HOLD A SLIP KNOT. PATIENTS ARE ABLE TO EASILY REMOVE THE RESTRAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959682 ↗
• MalfunctionNov 29, 2022Product Quality Problem; Product Quality Problem

  CUSTOMER STATES THE FOLLOWING: EVENT OR PROBLEM: HEALTH CARE PROVIDER NOTICED THE NEW TYPE OF POSEY RESTRAINTS THAT THEY GET ARE MADE OF A SLIPPERY MATERIAL. THIS MATERIAL HAS THE CAPABILITY OF COMING LOOSE AFTER BEING TIED TO THE BED FRAME. THIS ISSUE CAN CAUSE THE PATIENT TO PULL THEIR LINES OR ACCIDENTLY EXTUBATE THEMSELVES. THIS COMPLAINT WAS FILED ON PRODUCT # 2530 WITH LOT# 2172T025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15878561 ↗