Medline 7205306RRecalls & reported problems
Medline Industries, Inc. · 7205306 @FULL RADIUS BLADE (YELLOW) 4.5M · Class 2
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 10888277374997), received between Mar 18, 2019 and Nov 4, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break2
- Material Fragmentation1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2019Break
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE REPROCESSED DYONICS FULL RADIUS BLADE BROKE OFF IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9273945 ↗MalfunctionMar 18, 2019Break; Material Fragmentation
IT WAS REPORTED THAT THE REPROCESSED DYONICS FULL RADIUS BLADE BROKE WHILE IN USE AND METAL SHAVINGS WERE NOTED IN THE SURGICAL SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8429551 ↗
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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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