Sterile-Z 5574 (UDI 01618125140212)Recalls & reported problems
Tidi Products, LLC · Sterile-Z Surgical Patient Covers Clear Polyethylene Sterile Universal Fit 10 per Case · Class 2
Data updated Oct 18, 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 01618125140212), received between Nov 14, 2017 and Nov 14, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 18, 2026.
Most reported problems
Device problems
- Device Displays Incorrect Message1
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.
MalfunctionNov 14, 2017Device Displays Incorrect Message
CUSTOMER DESCRIBED THE WEIGHT OF THE DRAPE MOVED THE FRAME/TRACKER AND THEY ALSO SAID THE PLASTIC WAS INTERFERING WITH LIGHT CAUSING A SIGNAL ERROR. 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 7029602 ↗
Other Drape, surgical devices
- Medline DYNJP8002Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2410Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2414RMedline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2411Medline Industries, Inc. · Drape, surgical2 recalls2 reports
- Medline DYNJP2416Medline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP3008UGMedline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP2412TMedline Industries, Inc. · Drape, surgical2 recalls0 reports
- Medline DYNJP8412UGMedline 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page