IsolibriumRecalls & reported problems across all models
Stryker Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Isolibrium model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 1
We found 4 models of Isolibrium by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between May 7, 2018 and Apr 23, 2026 — classified as 20 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (13 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Reports received per month, all models
Isolibrium recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 12, 2021Open, Classified
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Z-2215-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Isolibrium problems
Device problems
- Adverse Event Without Identified Device or Use Problem17
- Electrical /Electronic Property Problem13
- Material Too Soft/Flexible9
- Insufficient Device Problem Information7
- Positioning Problem7
- Patient Device Interaction Problem3
- No Apparent Adverse Event2
- Patient-Device Incompatibility2
Patient problems
- Pressure Sore/Ulcer27
- No Clinical Signs, Symptoms or Conditions15
- Injury3
- Hyperemia2
- Insufficient Information2
- No Patient Involvement2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Isolibrium models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Isolibrium 2972BED, PATIENT ROTATION, POWERED1 recall17 reports
- Isolibrium 297300000000BED, PATIENT ROTATION, POWERED25 reports
- Isolibrium 2971BED, PATIENT ROTATION, POWERED11 reports
- Isolibrium 2972BED, PATIENT ROTATION, POWERED1 report
Recent Isolibrium adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Electrical /Electronic Property Problem
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1- MARCH 31, 2026. THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES 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 24966487 ↗MalfunctionJan 27, 2026Electrical /Electronic Property Problem
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1-DECEMBER 31, 2025. 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 24187836 ↗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
MalfunctionApr 28, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES 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 21919239 ↗MalfunctionJan 27, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT(S), 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 21242908 ↗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 ↗InjuryApr 16, 2024Inflation Problem; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE UNIT "WAS NOT INFLATING AND DEFLATING PROPERLY" AND THAT THIS CAUSED AN UNSPECIFIED PRESSURE INJURY.
Patient problems: Pressure Sore/Ulcer
MAUDE report 19119853 ↗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 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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