TIDIShield 5403 (UDI 01618125140038)Recalls & reported problems
Tidi Products, LLC · TIDIShield C-arm Equipment Covers Clear Polyethylene Sterile Fits OEC Mini 6800/6600 25 per Case · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 01618125140038), received between May 26, 2021 and May 26, 2021 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2021Break; Break
MEDICAL BARRIER SEAM WAS NOT INTACT, YIELDING OPEN AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11890035 ↗
Other Drape, surgical devices
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- Medline DYNJP2410Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2411Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP8002Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP3008UGMedline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP2416Medline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP4003Medline Industries, Inc. · Drape, surgical2 recalls0 reports
- Medline DYNJP2418Medline Industries, Inc. · Drape, surgical2 recalls0 reports
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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