Isolibrium 297300000000Recalls & reported problems
Stryker Corporation · Isolibrium PE · Class 2
All models of Isolibrium (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker Isolibrium is a powered hospital bed that rotates patients to help prevent pressure injuries. The 25 adverse event reports that name it mostly describe patients developing pressure sores or skin breakdown, along with complaints about positioning problems and mattress material being too soft. No deaths and 6 injuries are reported. No recalls name this device. Reports have risen recently, with 6 filed in the last 12 months compared with 2 in the prior year.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07613327523867), received between Oct 25, 2021 and Nov 21, 2025 — classified as 6 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Material Too Soft/Flexible” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem13
- Material Too Soft/Flexible8
- Positioning Problem7
- Patient Device Interaction Problem3
- Electrical /Electronic Property Problem2
- No Apparent Adverse Event2
- Sharp Edges2
- Material Too Rigid or Stiff1
Patient problems
- Pressure Sore/Ulcer17
- No Clinical Signs, Symptoms or Conditions5
- Hyperemia2
- Insufficient Information2
- Rash1
- Skin Discoloration1
- Skin Disorders1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2025Positioning Problem; Material Too Soft/Flexible; Positioning Problem; Material Too Soft/Flexible
MalfunctionNov 21, 2025Positioning Problem; Material Too Soft/Flexible; Positioning Problem; Material Too Soft/Flexible
MalfunctionNov 21, 2025Positioning Problem; Material Too Soft/Flexible; Positioning Problem; Material Too Soft/Flexible
MalfunctionNov 21, 2025Positioning Problem; Material Too Soft/Flexible; Positioning Problem; Material Too Soft/Flexible
MalfunctionNov 21, 2025Positioning Problem; Material Too Soft/Flexible; Positioning Problem; Material Too Soft/Flexible
MalfunctionNov 21, 2025Positioning Problem; Material Too Soft/Flexible; Positioning Problem; Material Too Soft/Flexible
MalfunctionJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS ORIGINALLY REPORTED THAT A PATIENT SUSTAINED A PRESSURE INJURY. IT WAS FURTHER REPORTED THAT THIS WAS A RASH AND NOT A SERIOUS INJURY.
Patient problems: Pressure Sore/Ulcer; Rash
MAUDE report 22636952 ↗MalfunctionJun 25, 2025Positioning Problem; Material Too Soft/Flexible; Positioning Problem; Material Too Soft/Flexible
MalfunctionJun 28, 2024Adverse Event Without Identified Device or Use Problem; Material Too Soft/Flexible; Adverse Event Without Identified Device or Use Problem; Material Too Soft/Flexible
IT WAS REPORTED THAT THE PATIENT SUFFERED AN UNSPECIFIED PRESSURE INJURY. IT WAS ALLEGED THAT THE MATTRESS WAS NOT INFLATING CORRECTLY, THOUGH UPON EVALUATION BY STRYKER TECHNICAL SERVICE THIS COULD NOT BE DUPLICATED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer
MAUDE report 19632341 ↗MalfunctionFeb 21, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED UNSPECIFIED SKIN ISSUES WHILE USING THE SURFACE. FURTHER INVESTIGATION IDENTIFIED THAT THE COMPLAINT THE INITIAL MDR WAS SUBMITTED UNDER WAS A DUPLICATE OF THE COMPLAINT WHICH MFR REPORT #0001831750-2024-00306 WAS SUBMITTED TO THE FDA UNDER. THIS RECORD WAS SUBMITTED IN ERROR AND DOES NOT REPRESENT A SEPARATE INCIDENT.
Patient problems: Unspecified Tissue Injury
MAUDE report 18752513 ↗MalfunctionFeb 9, 2024Material Too Rigid or Stiff; Patient Device Interaction Problem; Material Too Rigid or Stiff; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED ALLEGED SKIN ISSUES WHILE LAYING ON THE INTEGRATED MATTRESS. FURTHER INFORMATION HAS NOT BEEN PROVIDED.
Patient problems: Skin Discoloration; Skin Disorders
MAUDE report 18676932 ↗MalfunctionOct 24, 2023Sharp Edges; Sharp Edges
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17998904 ↗MalfunctionJun 28, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
IT WAS REPORTED DURING TURNING OF THE PATIENT, MULTIPLE CIRCLE PATTERNS WERE NOTED TO THE BILATERAL THIGHS & COCCYX AREA.
Patient problems: Hyperemia; Insufficient Information
MAUDE report 17219637 ↗MalfunctionJun 28, 2023Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
IT IS REPORTED THAT A NURSE WENT TO TURN A PATIENT AND 3 CIRCLE PATTERNS WERE NOTED ON THE LEFT THIGH.
Patient problems: Hyperemia; Insufficient Information
MAUDE report 17219626 ↗InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS ALLEGED THAT THE DEVICE IS CAUSING BED SORES/WOUNDS ON A PATIENT'S BACK/BACK OF LEGS. UPON EVALUATION PERFORMED BY A TECHNICIAN, NO APPARENT DEVICE MALFUNCTION OR DEFECT WAS FOUND.
Patient problems: Pressure Sore/Ulcer
MAUDE report 16755901 ↗MalfunctionMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER HAD A PATIENT EXPERIENCE MINOR PRESSURE INJURIES ON AN ISOLIBRIUM PE SUPPORT SURFACE. A STRYKER REPRESENTATIVE CHECKED ALL OF THE CUSTOMER'S ISOLIBRIUM PE UNITS AND ALL WERE FOUND TO BE OPERATING CORRECTLY, LIKELY INDICATING THAT THE ALLEGED INJURIES WERE THE RESULT OF USE ERROR AND NOT DUE TO ANY FAILURE OF THE STRYKER PRODUCTS.
Patient problems: Pressure Sore/Ulcer
MAUDE report 16636513 ↗MalfunctionMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER HAD A PATIENT EXPERIENCE MINOR PRESSURE INJURIES ON AN ISOLIBRIUM PE SUPPORT SURFACE. A STRYKER REPRESENTATIVE CHECKED ALL OF THE CUSTOMER'S ISOLIBRIUM PE UNITS AND ALL WERE FOUND TO BE OPERATING CORRECTLY, LIKELY INDICATING THAT THE ALLEGED INJURIES WERE THE RESULT OF USE ERROR AND NOT DUE TO ANY FAILURE OF THE STRYKER PRODUCTS.
Patient problems: Pressure Sore/Ulcer
MAUDE report 16636508 ↗InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SEVERELY ILL HIGH RISK WITH LOW MOBILITY PATIENT SUSTAINED A DEEP TISSUE INJURY. THROUGH COMMUNICATION WITH THE CUSTOMER, IT WAS REPORTED THAT THE MATTRESS WAS NOT DEFLATED. TREATMENT INFORMATION WAS NOT ABLE TO BE OBTAINED.
Patient problems: Pressure Sore/Ulcer
MAUDE report 16405385 ↗InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SEVERELY ILL HIGH RISK WITH LOW MOBILITY PATIENT SUSTAINED A DEEP TISSUE INJURY. THROUGH COMMUNICATION WITH THE CUSTOMER, IT WAS REPORTED THAT THE MATTRESS WAS NOT DEFLATED. TREATMENT INFORMATION WAS NOT ABLE TO BE OBTAINED.
Patient problems: Pressure Sore/Ulcer
MAUDE report 16405293 ↗InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SEVERELY ILL HIGH RISK WITH LOW MOBILITY PATIENT SUSTAINED A DEEP TISSUE INJURY. THROUGH COMMUNICATION WITH THE CUSTOMER, IT WAS REPORTED THAT THE MATTRESS WAS NOT DEFLATED. TREATMENT INFORMATION WAS NOT ABLE TO BE OBTAINED.
Patient problems: Pressure Sore/Ulcer
MAUDE report 16405034 ↗InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SEVERELY ILL HIGH RISK WITH LOW MOBILITY PATIENT SUSTAINED A DEEP TISSUE INJURY. THROUGH COMMUNICATION WITH THE CUSTOMER, IT WAS REPORTED THAT THE MATTRESS WAS NOT DEFLATED. TREATMENT INFORMATION WAS NOT ABLE TO BE OBTAINED.
Patient problems: Pressure Sore/Ulcer
MAUDE report 16405031 ↗InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SEVERELY ILL HIGH RISK WITH LOW MOBILITY PATIENT SUSTAINED A DEEP TISSUE INJURY. THROUGH COMMUNICATION WITH THE CUSTOMER, IT WAS REPORTED THAT THE MATTRESS WAS NOT DEFLATED. TREATMENT INFORMATION WAS NOT ABLE TO BE OBTAINED.
Patient problems: Pressure Sore/Ulcer
MAUDE report 16404988 ↗MalfunctionApr 25, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE AC CURRENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14193790 ↗MalfunctionJan 19, 2022Electrical /Electronic Property Problem; No Apparent Adverse Event; Electrical /Electronic Property Problem; No Apparent Adverse Event
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED EXPOSED BARE WIRES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13289834 ↗MalfunctionOct 25, 2021Sharp Edges; Sharp Edges
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12693712 ↗
Other BED, PATIENT ROTATION, POWERED devices
- Isolibrium 2972Stryker Corporation · BED, PATIENT ROTATION, POWERED1 recall17 reports
- Isolibrium 2971Stryker Corporation · BED, PATIENT ROTATION, POWERED11 reports
- Pronova-O2 1Turn Medical, LLC · Bed, Patient Rotation, Powered2 reports
- Isolibrium 2972Stryker Corporation · BED, PATIENT ROTATION, POWERED1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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