Mepilex® Border Flex Lite 581200Recalls & reported problems
Mölnlycke Health Care AB · Mepilex Border Flex Lite 7,5x7,5cm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07323190249459), received between May 7, 2026 and May 7, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
Patient problems
- Pressure Sore/Ulcer1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2026Improper or Incorrect Procedure or Method; Insufficient Device Problem Information
The product that I was using was Mepilex Border Lite which was a very good product to prevent pressure sores on my neck and it was quietly replaced with Mepilex Border Flex Lite which is thinner, flimsier, and falls off more often. I have been using the first one all the time in the past and in recent months I started feeling more pain and noticed it coming off more easily and a significant pressure wound now.The open ulcer is bleeding, swollen and very red. I have previously been using Mepilex Border Lite when it first opened a few years ago and has been manageable until I received Mepilex Border Flex Lite which have less padding (I have an old one and a side by side comparison shows the new ones are not as padded.There is no medical device applied to the neck. I required a doctor visit as well as Wound Care Nurse and both of them notice the difference in quality. They are trying to put more padding to prevent bone infection. I also have nurses overnight for my Spinal Muscular Atrophy and they are monitoring as well.The dressings are changed every day or two - often sooner because Mepilex Border Flex Lite falls off more frequently than Mepilex Border Lite.The number from one of th
Patient problems: Pressure Sore/Ulcer
MAUDE report 25110444 ↗
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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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