IsoFlex LAL 2860 (REF 2860-000-026)Recalls & reported problems
Stryker Corporation · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327278514), received between Feb 17, 2020 and Apr 3, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 16, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem2
Patient problems
- Pressure Sore/Ulcer1
- Skin Discoloration1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT PATIENTS ARE EXPERIENCING SKIN REDNESS AFTER LAYING ON THE ISOFLEX MATTRESSES. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Patient problems: Skin Discoloration
MAUDE report 9923282 ↗InjuryFeb 17, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT SUFFERED PRESSURE INJURIES ON THEIR ABDOMEN. THE WOUNDS WERE TREATED WITH SPECIAL WOUND DRESSINGS. THE CUSTOMER IS NOT ALLEGING THE MATTRESS CAUSED OR CONTRIBUTED DIRECTLY TO THE INJURY.
Patient problems: Pressure Sore/Ulcer
MAUDE report 9717292 ↗
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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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