POSEY 2532Recalls & reported problems
Posey Products, LLC · FOAM LIMB HOLDER · Class 1
Quick summary
This Posey foam limb holder is a soft restraint used to keep a patient's limbs still in bed. The 36 reports mostly describe the holder slipping or coming undone — buckles and clips releasing, knots loosening, and the material tearing — so patients could wriggle free or pull at their tubing; a few mention a patient pulling out their own tube. No deaths or injuries were reported in any of them, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10190676004789), received between Jan 10, 2023 and Feb 4, 2026 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Device Slipped” (26 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.
Reports received per month
Most reported problems
Device problems
- Device Slipped26
- Mechanical Problem4
- Material Disintegration2
- Break1
- Defective Device1
- Material Split, Cut or Torn1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Concussion1
- Unintended Extubation1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2026Device Slipped
CUSTOMER REPORTING COMPLAINT ON PRODUCT#: 2532. THE CUSTOMER STATES THAT THE PATIENT WAS ABLE TO FREE THEMSELVES FROM THE RESTRAINT. LOT#: 3293T027. THIS WAS DUE TO A CLIP FAILURE IT IS STATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261035 ↗MalfunctionAug 5, 2025Device Slipped; Device Slipped
CUSTOMER REPORTED INCIDENT WHERE SOMEONE UNCLIPPED THE RESTRAINT, WE DID MOVE THE BUCKLES LOWER AND FROM WHAT IS BEING DESCRIBED TO ME, THIS CREATES EXTRA SLACK IN THE RESTRAINT THAT ALLOWS A PATIENT TO WRIGGLE AND GET TO THEIR TUBE. PATIENT DID SELF EXTUBATE.
Patient problems: Unintended Extubation
MAUDE report 22722039 ↗MalfunctionAug 5, 2025Device Slipped; Device Slipped
CUSTOMER REPORTED PEDIATRIC INCIDENT WHERE SOMEONE UNCLIPPED THE RESTRAINT. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22721524 ↗MalfunctionMay 17, 2024Device Slipped; Device Slipped
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2532. CUSTOMER STATES THE TEETH ARE SLIPPING & PATIENTS ARE ABLE TO GET OUT OF THEIR RESTRAINTS. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19344043 ↗MalfunctionMay 16, 2024Break; Break
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2532. CUSTOMER STATES DURING A DEMOSTRATION THAT AN RN WAS STRUGGLING WITH RESTRAINT APPLIED SIMULATING AS IF A PATIENT WAS WEARING THE RESTRAINT. THE RN WAS ABLE TO TEAR THE RESTRAINT IN HALF. CUSTOMER HAS THE RESTRAINT FOR EVALUATION LOT # 4011T057.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19336734 ↗MalfunctionMay 16, 2024Device Slipped; Device Slipped
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2532. CUSTOMER STATES THAT KNOTS ON THE RESTRAINTS ARE LOOSENING EASILY. THIS IS HAPPENING AFTER THEY TIE THE KNOT SO THE RESTRAINT WILL NOT LOOSEN FROM THE BED. CUSTOMER STATES THIS IS PART OF LOT # 3355T050.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19334654 ↗MalfunctionApr 17, 2024Device Slipped; Device Slipped
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2532.CUSTOMER IS STATING THEY HAVE A CASE OF LOT # 3345 AND BELOW. THESE LOTS HAVE A BUCKLE ISSUE WITH SLIPPAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19126113 ↗MalfunctionApr 15, 2024Device Slipped; Device Slipped
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2532. CUSTOMER WOULD LIKE TO RETURN QTY (B)(4) OF THE 2532. THIS IS RELATED TO THE BUCKLE SLIPPING RETURN ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19104636 ↗MalfunctionApr 10, 2024Device Slipped; Device Slipped
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2532. CUSTOMER STATES THAT THEY HAVE BEEN HAVING TROUBLE OVER THE LAST COUPLE OF MONTHS WITH THE 2532. PATIENTS CAN LOOSEN THE RESTRAINT EASILY WHEN THEY PULL ON THEM. CUSTOMER IS CONCERNED THIS WILL KEEP HAPPENING. CUSTOMER ALSO STATES THE "NEW" MATERIAL FEELS SMOOTHER AND SLIDES EASIER THROUGH THE BUCKLES/CLIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19082418 ↗MalfunctionApr 10, 2024Device Slipped; Device Slipped
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2532. CUSTOMER STATES THIS IS REGARDING A BUCKLE ISSUE WITH THE 2532. THERE WERE NO PATIENT INCIDENT OR INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19082114 ↗MalfunctionApr 10, 2024Device Slipped; Device Slipped
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2532. CUSTOMER STATES THAT A PATIENT WAS ABLE TO LOOSEN THEIR 2532 RESTRAINT. THE RESTRAINT WAS TIGHTENED AND THE PATIENT WAS ABLE TO LOOSEN IT MULTIPLE TIMES. FDA MEDWATCH REPORT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19081994 ↗MalfunctionApr 4, 2024Device Slipped; Device Slipped
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2532. CUSTOMER REPORTED COMPLAINT WITH BUCKLE SLIPPPAGE ISSUE. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19042785 ↗MalfunctionApr 3, 2024Device Slipped; Device Slipped
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2532. CUSTOMER REPORTED BUCKLE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19035376 ↗MalfunctionMar 27, 2024Device Slipped; Device Slipped
SUPPLEMENTAL MEDWATCH BEING SENT FOR ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18988877 ↗MalfunctionMar 26, 2024Device Slipped; Device Slipped
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2532. CUSTOMER STATES THIS BUCKLE SLIPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18980972 ↗MalfunctionMar 20, 2024Device Slipped; Device Slipped
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2532. CUSTOMER STATES THAT THE BUCKLES DO NOT STOP THE STRAP FROM MOVING. THIS IS ALLOWING PATIENTS TO SLIP OR BREAK OUT OF THE RESTRAINT. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18940849 ↗MalfunctionMar 20, 2024Device Slipped; Device Slipped
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # 2532. CUSTOMER STATES THAT THE BUCKLES DO NOT STOP THE STRAP FROM MOVING. THIS IS ALLOWING PATIENTS TO SLIP OR BREAK OUT OF THE RESTRAINT. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18940822 ↗MalfunctionMar 15, 2024Off-Label Use; Off-Label Use
CUSTOMER REPORTING A COMPLAINT ON PRODUCT # (B)(4). CUSTOMER STATES THAT THE HOSPITAL HAD AN EVENT OVER THE WEEKEND WITH THE 2532 BEING INVOLVED. A STAFF MEMBER WAS INJURED IN THE PROCESS OF THE EVENT.
Patient problems: Concussion
MAUDE report 18912687 ↗MalfunctionFeb 28, 2024Device Slipped; Device Slipped
CUSTOMER REPORTED RESTRAINT LOOSENED BY PATIENT WITH MINIMAL EFFORT DESPITE HAVING BEEN ASSESSED BY RN PRIOR TO EVENT. RESTRAINTS WERE APPROPRIATELY APPLIED. PATIENT FOUND TO HAVE LOOSENED RIGHT RESTRAINT AND REMOVED ET TUBE. MULTIPLE STAFF RESPONDED BEDSIDE IMMEDIATELY TO FIND RESTRAINT STILL ATTACHED AND CLIPPED TO BED BUT LOOSE ENOUGH FOR PATIENT TO REACH TUBE. LEFT RESTRAINT STILL IN PLACE BUT ALSO FOUND TO BE LOOSENED BY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18797652 ↗MalfunctionFeb 22, 2024Device Slipped; Device Slipped
COMPLAINT SENT VIA EMAIL TO QA. LOT #S PER CUSTOMER: (B)(6). PATIENT INJURY, LOW SEVERITY. CAUSE DESCRIPTION: FAILURE ALREADY DETERMINED BY MANUFACTURER. INCIDENT DATE LISTED AS (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18764121 ↗MalfunctionFeb 1, 2024Device Slipped; Device Slipped
CUSTOMER REPORTED: A PATIENT IN THE ICU WAS INTUBATED AND SEDATED, WAS PLACED IN THE QUICK-RELEASE SOFT RESTRAINTS TO PREVENT INADVERTENT REMOVAL OF BREATHING TUBE, CENTRAL LINE, PA CATHETER, ETC. THE RN WENT TO LUNCH AND ANOTHER RN WALKED BY THE PATIENTS ROOM AND SAW THEM SITTING FULL UPRIGHT IN BED WITH HIS HAND AROUND HIS ENDOTRACHEAL TUBE WITH THE INTENT TO REMOVE IT. WHEN THE PATIENT HAD PULLED ON THE RESTRAINT THE PLASTIC TEETH HAD NOT STOPPED THE STRAP FROM SLIDING TO ITS LONGEST POINT ALLOWING THE PATIENT TO FULLY MOVE HIS ARM. PER OTHER NURSES WHO ASSISTED WITH RE-RESTRAINING THE PATIENT, THIS HAS HAPPENED WITH OUR RESTRAINTS PREVIOUSLY. UPON EXAMINATION OF THE RESTRAINT, NOTHING WAS BROKEN- THE PLASTIC TEETH HAD SIMPLY NOT PROVIDED RESISTANCE TO KEEP THE STRAP FROM SLIDING THROUGH WHEN PULLED. THIS PATIENT IS IN RESPIRATORY FAILURE AND REQUIRES VENTILATION FOR SURVIVAL RIGHT NOW. IF HE HAD BEEN ABLE TO PULL OUT HIS ENDOTRACHEAL TUBE, IT WOULD HAVE SEVERELY NEGATIVELY IMPACTED HIS HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18623296 ↗MalfunctionJan 17, 2024Device Slipped; Device Slipped
SUPPLEMENTAL MEDWATCH BEING SENT FOR ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531400 ↗MalfunctionDec 15, 2023Device Slipped; Device Slipped
CUSTOMER IS REPORTING COMPLAINT ON PRODUCT # 2532. CUSTOMER STATES THAT THEY HAVE A CONCERN ABOUT THE RESTRAINT SLIPPING AT THE WHITE FASTENERS. THEY HAVE MULTIPLE COMPLAINTS FROM THE SAME PRODUCT. LOT # 3229T044 OR 3250T279.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18336221 ↗MalfunctionDec 15, 2023Device Slipped; Device Slipped
CUSTOMER IS REPORTING COMPLAINT ON PRODUCT # (B)(4). . CUSTOMER STATES THAT THEY HAVE A CONCERN ABOUT THE RESTRAINT SLIPPING AT THE WHITE FASTENERS. THEY HAVE MULTIPLE COMPLAINTS FROM THE SAME PRODUCT. LOT # 3229T044 OR 3250T279.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18336219 ↗MalfunctionOct 20, 2023Device Slipped; Device Slipped
CUSTOMER IS REPORTING A COMPLAINT ON PRODUCT 2532, LOT# 3159T092. CUSTOMER REPORTS THAT OVER THE WEEKEND MULTIPLE PATIENTS WERE ABLE TO SELF EXTUBATE BECAUSE THE RESTRAINTS TEETH DID NOT GRAB OR LOCK IN WHEN THERE WAS PULL ON THE RESTRAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17976122 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.