IsoTourRecalls & reported problems across all models

We found 3 models of IsoTour by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Apr 27, 2020 and Jul 25, 2025 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported IsoTour problems

IsoTour models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• IsoTour 2872

  MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
  9 reports
• IsoTour 2872

  MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
  9 reports
• IsoTour 2874

  MATTRESS, FLOTATION THERAPY, NON-POWERED
  4 reports

Recent IsoTour adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE AC CURRENT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608934 ↗
• MalfunctionOct 4, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THERE WAS AN INCREASE IN UNSPECIFIED PRESSURE INJURIES. SPECIFIC NUMBERS, SEVERITY OF INJURY, AND TREATMENT DETAILS HAVE NOT BEEN PROVIDED AT THE TIME OF REPORTING.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 20369659 ↗
• MalfunctionSep 6, 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 GEL SECTIONS ON THE DEVICE ARE SEPARATING. IT WAS FURTHER REPORTED THAT THE PATIENT HAS A WORSENING PRESSURE INJURY.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 20161596 ↗
• MalfunctionMar 29, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT A STAFF MEMBER WAS INJURED DUE TO THE WEIGHT OF THE ISOTOUR MATTRESS DURING CLEANING. IT WAS FURTHER REPORTED THAT A USER RECEIVED FIRST AID.

  Patient problems: Insufficient Information

  MAUDE report 19007612 ↗
• MalfunctionMar 29, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THERE WAS NEAR MISS INJURY WITH A USER DUE TO THE WEIGHT OF THE ISOTOUR MATTRESS DURING CLEANING, BUT NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19007602 ↗
• MalfunctionNov 28, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT A STAFF MEMBER WAS INJURED DUE TO THE WEIGHT OF THE ISOTOUR MATTRESS DURING CLEANING. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL INJURY AND TREATMENT DETAILS FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 18222451 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, WHILE USING THE SURFACE, THE PATIENT COMPLAINED OF PAIN IN THEIR SACRAL AREA. IT WAS DISCOVERED THAT THE SURFACES GEL HAD SEPARATED, AND THE PATIENT WAS SITTING ON THE FRAME OF THE MATTRESS. THE PATIENT SUSTAINED A NEW STAGE 2 PRESSURE INJURY.

  Patient problems: Pain; Pressure Sore/Ulcer

  MAUDE report 18183431 ↗
• MalfunctionJul 19, 2023Sharp Edges; Sharp Edges

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17350153 ↗
• MalfunctionApr 26, 2023Electrical /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 16815505 ↗
• MalfunctionApr 26, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED MATTRESS HEAVY/HARD TO MOVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209264 ↗
• MalfunctionApr 25, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  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 14193781 ↗
• MalfunctionJul 27, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE WAS TOO HEAVY/DIFFICULT TO MOVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12234214 ↗
• MalfunctionJun 9, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT SUSTAINED A DEEP TISSUE INJURY WHILE USING THE ISOTOUR SURFACE. FURTHER INVESTIGATION IDENTIFIED THAT THE ISOTOUR SURFACE HAD NOT MALFUNCTIONED AND HAD NOT CONTRIBUTED TO THE ALLEGED INJURY IN ANY WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer

  MAUDE report 11970293 ↗
• MalfunctionJun 8, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT SUSTAINED A PRESSURE INJURY WHILE USING THE ISOTOUR SURFACE IN THE ICU. THE USER FACILITY STATED THAT ALL TURNING AND INJURY PREVENTION PROTOCOLS WERE FOLLOWED; HOWEVER, DUE TO THE PATIENT'S SKIN CONDITION AND BRADEN SCORES THEY WERE AT RISK FOR DEVELOPING A PRESSURE INJURY BEFORE BEING PLACED ON THE ISOTOUR SURFACE. THERE ARE A NUMBER OF DIFFERENT FACTORS THAT CONTRIBUTE TO PRESSURE INJURIES, SUCH AS NUTRITION, SKIN CONDITION, MOISTURE AND PRESSURE INJURY TREATMENT PROTOCOL. GIVEN THAT ALL FACTORS THAT ARE WITHIN STRYKER¿S CONTROL WERE EVALUATED AND FOUND TO BE OPERATING AS INTENDED, IT WAS DETERMINED THAT THERE WERE NO DEFECTS FOUND WITH THE ISOTOUR SURFACE THAT WOULD HAVE POTENTIALLY CAUSED OR CONTRIBUTED TO THE ALLEGED PRESSURE INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer

  MAUDE report 11962223 ↗
• MalfunctionJun 8, 2021Patient-Device Incompatibility; No Apparent Adverse Event; Patient-Device Incompatibility; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT SUSTAINED A PRESSURE INJURY WHILE USING THE ISOTOUR SURFACE IN THE ICU. THE USER FACILITY STATED THAT ALL TURNING AND INJURY PREVENTION PROTOCOLS WERE FOLLOWED; HOWEVER, DUE TO THE PATIENT'S SKIN CONDITION AND BRADEN SCORES THEY WERE AT RISK FOR DEVELOPING A PRESSURE INJURY BEFORE BEING PLACED ON THE ISOTOUR SURFACE. THERE ARE A NUMBER OF DIFFERENT FACTORS THAT CONTRIBUTE TO PRESSURE INJURIES, SUCH AS NUTRITION, SKIN CONDITION, MOISTURE AND PRESSURE INJURY TREATMENT PROTOCOL. GIVEN THAT ALL FACTORS THAT ARE WITHIN STRYKER¿S CONTROL WERE EVALUATED AND FOUND TO BE OPERATING AS INTENDED, IT WAS DETERMINED THAT THERE WERE NO DEFECTS FOUND WITH THE ISOTOUR SURFACE THAT WOULD HAVE POTENTIALLY CAUSED OR CONTRIBUTED TO THE ALLEGED PRESSURE INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer

  MAUDE report 11961934 ↗

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