Halyard 89731Recalls & reported problems
O&M Halyard, Inc. · UTILITY DRAPE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651897319), received between May 23, 2023 and May 23, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Product Quality Problem” (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
- Product Quality Problem1
Patient problems
- Foreign Body Sensation in Eye1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2023Product Quality Problem; Product Quality Problem
THE CUSTOMER NOTED THERE WAS LINTING FROM THE DRAPE INTO THE PATIENT'S EYES. SHE STATED THAT THE ISSUE WAS RESOLVED BY USING A SALINE WASH TO REMOVE THE LINT. NO INJURY OR LONG-TERM EFFECTS WERE REPORTED AS A RESULT OF THE ISSUE.
Patient problems: Foreign Body Sensation in Eye
MAUDE report 16985453 ↗
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- 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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