TIDIShield 5403 (UDI 00618125140039)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
- 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 00618125140039), received between May 8, 2024 and Feb 19, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Puncture/Hole2
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.
MalfunctionFeb 19, 2025Material Puncture/Hole; Material Puncture/Hole
COMPLAINT#: (B)(4) BEFORE PROCEDURE, PARTIALLY TORN DRAPE WAS FOUND WHEN OPENING THE PACKAGE. AS A RESULT, THE DRAPE WAS RETURNED AND REVIEWED AT GADELIUS MEDICAL K.K. THE TORN DRAPE, 18CM LONG (7.1" LONG), WAS CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21413709 ↗MalfunctionMay 8, 2024Material Puncture/Hole; Material Puncture/Hole
4/69/24-LK COMPLAINT #OT-149 BEFORE PROCEDURE, PARTIALLY TORN DRAPE WAS FOUND WHEN OPENING THE PACKAGE. AS A RESULT OF THE RETURNED SAMPLE(S) REVIEW AT GMKK: THE TORN DRAPE, 37CM LONG(14.5" LONG), WAS CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19274208 ↗
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- Medline DYNJP8304AMedline Industries, Inc. · Drape, surgical, exempt3 recalls0 reports
- Medline DYNJP9103Medline Industries, Inc. · Drape, surgical, exempt2 recalls7 reports
- Medline DYNJP8201Medline Industries, Inc. · Drape, surgical, exempt2 recalls6 reports
- Medline DYNJP6006Medline Industries, Inc. · Drape, surgical, exempt2 recalls4 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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