Hemo-Force MDS601M2Recalls & reported problems
Medline Industries, Inc. · GARMENT,MEDLINE,DVT,INT,CALF,MED, GEN2 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888277348134), received between Mar 31, 2026 and Apr 20, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Increase in Pressure” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Increase in Pressure4
Patient problems
- Insufficient Information4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2026Increase in Pressure
CUSTOMER HAS REPORTED SOME SKIN PRESSURE ISSUES SINCE THEY CONVERTED TO OUR # MDS601M2BL.
Patient problems: Insufficient Information
MAUDE report 24932004 ↗MalfunctionApr 20, 2026Increase in Pressure
CUSTOMER HAS REPORTED SOME SKIN PRESSURE ISSUES SINCE THEY CONVERTED TO OUR # MDS601M2BL.
Patient problems: Insufficient Information
MAUDE report 24930530 ↗MalfunctionApr 20, 2026Increase in Pressure
CUSTOMER HAS REPORTED SOME SKIN PRESSURE ISSUES SINCE THEY CONVERTED TO OUR # MDS601M2BL.
Patient problems: Insufficient Information
MAUDE report 24927505 ↗MalfunctionMar 31, 2026Increase in Pressure
CUSTOMER HAS REPORTED SOME SKIN PRESSURE ISSUES SINCE THEY CONVERTED TO OUR # MDS601M2BL
Patient problems: Insufficient Information
MAUDE report 24743807 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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