Halyard 89347Recalls & reported problems
O&M Halyard, Inc. · HYH,ORTHOU,DRAPE,-,-,10 · 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 10680651893472), received between Sep 10, 2025 and Sep 10, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Accessory Incompatible” (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.
Reports received per month
Most reported problems
Device problems
- Accessory Incompatible1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2025Accessory Incompatible; Accessory Incompatible
A PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE DRAPE RESULTING IN A RASH ON THE CHEST, BUTTOCKS, AND BOTH THE UPPER AND LOWER ABDOMEN. THE PATIENT SOUGHT MEDICAL TREATMENT WHICH INCLUDED ORAL STEROIDS AND A TOPICAL STEROID CREAM APPLIED FOR SEVERAL WEEKS. THE PATIENT IS KNOWN TO HAVE ALLERGIES TO ADHESIVE AND DERMABOND.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 23017209 ↗
Other Drape, surgical devices
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- 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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