Halyard 70681Recalls & reported problems
O&M Halyard, Inc. · DAVIS EYE DRAPE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30680651706813), received between Apr 7, 2026 and Apr 7, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Accessory Incompatible” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Accessory Incompatible2
Patient problems
- Corneal Abrasion2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Accessory Incompatible
RECEIVED NOTIFICATION FROM MEDLINE THAT CUSTOMER REPORTED "CORNEAL ABRASIONS" RELATED TO THE DRAPE. END-USER REPORTED THAT THERE IS A THICKER CLEAR ADHESIVE AREA THAT IS CAUSING ABRASIONS TO CORNEAS. THE CUSTOMER DID NOT SPECIFY A QUANTITY OF PATIENT(S) IMPACTED. ADDITIONAL DETAILS WERE REQUESTED; HOWEVER, THE HOSPITAL RESPONDENT INDICATED QUANTITY OF PATIENTS AFFECTED, MEDICAL TREATMENT AND FURTHER PATIENT DETAILS WERE UNKNOWN.
Patient problems: Corneal Abrasion
MAUDE report 24798640 ↗InjuryApr 7, 2026Accessory Incompatible
RECEIVED NOTIFICATION FROM MEDLINE THAT CUSTOMER REPORTED "CORNEAL ABRASIONS" RELATED TO THE DRAPE. END-USER REPORTED THAT THERE IS A THICKER CLEAR ADHESIVE AREA THAT IS CAUSING ABRASIONS TO CORNEAS. THE CUSTOMER DID NOT SPECIFY A QUANTITY OF PATIENT(S) IMPACTED. ADDITIONAL DETAILS WERE REQUESTED; HOWEVER, THE HOSPITAL RESPONDENT INDICATED QUANTITY OF PATIENTS AFFECTED, MEDICAL TREATMENT AND FURTHER PATIENT DETAILS WERE UNKNOWN.
Patient problems: Corneal Abrasion
MAUDE report 24798513 ↗
Other Drape, surgical, exempt devices
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- Medline DYNJP2498Medline Industries, Inc. · Drape, Surgical, Exempt3 recalls1 report
- Medline DYNJP8005UGMedline Industries, Inc. · Drape, Surgical, Exempt3 recalls0 reports
- Medline DYNJP3103Medline Industries, Inc. · Drape, Surgical, Exempt3 recalls0 reports
- Medline DYNJP8304AMedline Industries, Inc. · Drape, surgical, exempt3 recalls0 reports
- Medline DYNJP9103Medline Industries, Inc. · Drape, surgical, exempt2 recalls7 reports
- Medline DYNJP8201Medline Industries, Inc. · Drape, surgical, exempt2 recalls6 reports
- Medline DYNJP6006Medline Industries, Inc. · Drape, surgical, exempt2 recalls4 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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