C-Armor 5536Recalls & reported problems
Tidi Products, LLC · C-Armor C-arm Equipment Covers Clear Sterile Universal Fit 12 per Case · Class 2
Data updated Oct 13, 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 01618125140168), received between Aug 17, 2018 and Aug 17, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Microbial Contamination of Device” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Microbial Contamination of Device1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2018Microbial Contamination of Device; Microbial Contamination of Device
CUSTOMER REPORTED A FOREIGN MATERIAL, POSSIBLY A BUG, WAS FOUND INSIDE THE SEALED AND STERILE PACKAGE OF A DRAPE COVER. NO FURTHER INFORMATION WAS PROVIDED. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7795162 ↗
Other Drape, surgical devices
- Medline DYNJP8002Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2414RMedline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2411Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2410Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2416Medline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP3008UGMedline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP8201UGMedline Industries, Inc. · Drape, surgical2 recalls0 reports
- Medline DYNJP2412TMedline 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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