IsoFlex LAL 2860 (REF 2860-000-019)Recalls & reported problems
Stryker Corporation · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327278507), received between Oct 11, 2019 and May 3, 2022 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Difficult or Delayed Positioning1
- Pressure Problem1
Patient problems
- Pressure Sore/Ulcer4
- Injury1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A HOSPITAL ACQUIRED PRESSURE INJURY THAT WAS FOUND BY A WOCN. THE PRESSURE INJURY WAS UNSTAGEABLE AND REPORTED AS A DEEP TISSUE PRESSURE INJURY. THE INJURY WAS DESCRIBED AS A STRAIGHT LINE ACROSS THE SACRAL REGION. THE PATIENT WAS DISCHARGED AND NO ADDITIONAL MEDICAL TREATMENT WAS REQUIRED FOR HOSPITAL ACQUIRED PRESSURE INJURY THAT THEY KNOW OF.
Patient problems: Pressure Sore/Ulcer
MAUDE report 14270491 ↗InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT SUSTAINED AN UNSTAGEABLE PRESSURE INJURY WHILE ON A STRYKER SURFACE. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL DETAILS FROM THE USER FACILITY.
Patient problems: Pressure Sore/Ulcer
MAUDE report 13688635 ↗InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE HOSPITAL IS EXPERIENCING A GENERAL INCREASE IN PRESSURE INJURIES ON STRYKER SURFACES. ATTEMPTS ARE BEING MADE TO GATHER ADDITIONAL DETAILS FROM THE USER FACILITY.
Patient problems: Pressure Sore/Ulcer
MAUDE report 13651521 ↗MalfunctionApr 23, 2021Difficult or Delayed Positioning; Difficult or Delayed Positioning
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THAT THE MATTRESS WAS HEAVY AND/OR HARD TO MOVE. THERE WAS 1 INSTANCE WITH PATIENT INVOLVEMENT; WHERE A USER EXPERIENCED PAIN.
Patient problems: Pain
MAUDE report 11715486 ↗InjuryOct 11, 2019Pressure Problem
IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE NOTED A GENERAL INCREASE IN PRESSURE INJURIES SINCE PURCHASING THE MATTRESSES. NO SPECIFIC INSTANCES WERE REPORTED.
Patient problems: Injury; Pressure Sore/Ulcer
MAUDE report 9180972 ↗
Other BED, FLOTATION THERAPY, POWERED devices
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- pro+ P7924ARENT01Hill-Rom, Inc. · Bed, Flotation Therapy, Powered3 recalls1 death15 reports
- pro+ P3255A02Hill-Rom, Inc. · BED, FLOTATION THERAPY, POWERED3 recalls8 reports
- pro+ P7924A01Hill-Rom, Inc. · BED, FLOTATION THERAPY, POWERED3 recalls4 reports
- pro+ P3255A01Hill-Rom, Inc. · BED, FLOTATION THERAPY, POWERED3 recalls3 reports
- pro+ P7923A03Hill-Rom, Inc. · BED, FLOTATION THERAPY, POWERED3 recalls2 reports
- pro+ P7923A04Hill-Rom, Inc. · BED, FLOTATION THERAPY, POWERED3 recalls0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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