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Sterile-Z 5574 (UDI 00618125140213)Recalls & reported problems

Tidi Products, LLC · Sterile-Z Surgical Patient Covers Clear Polyethylene Sterile Universal Fit 10 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 00618125140213), received between Oct 20, 2017 and Oct 20, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

  • Device Operates Differently Than Expected1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 20, 2017Device Operates Differently Than Expected

    A CUSTOMER REPORTED THAT DURING A SPINAL FUSION PROCEDURE, WHILE IN USE OF THE STERILE-Z PATIENT DRAPE, THE DRAPE MAY HAVE CONTRIBUTED WITH THE DRIVER ACCURACY BEING OFF. THIS CAUSED A DELAY TO THE PROCEDURE. THE DATE WHEN THE ISSUE OCCURRED IS UNKNOWN. IT WAS REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT. THIS IS THE INITIAL REPORT AND TIDI IS IN THE PROCESS OF OBTAINING FURTHER INFORMATION AND WILL BE INVESTIGATING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6966824 ↗

Other Drape, Surgical, Exempt devices

All Drape, Surgical, Exempt devices →

Sources and updates

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