Medline Industries, Inc. DYNJ55959FRecalls & reported problems
Medline Industries, Inc. · SKIN PACK II SS · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327645991), received between Aug 11, 2026 and Sep 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Dull, Blunt1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break; Dull, Blunt
It was reported that "Last week, a scalpel completely broke during a recovery". It was also reported that "several of the staff have complained that the scalpels are extremely dull and difficult to work with".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946500 ↗MalfunctionAug 11, 2026Material Integrity Problem
It was reported that the corner of the bag gradually tore, resulting in the heart being recovered for research falling to the floor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216593 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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