Halyard 69520Recalls & reported problems
O&M Halyard, Inc. · HALYARD* Surgical Cap-3-Layer SMS on Sides, Spunbond on Top · Class 1
- 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 20680651695202), received between Feb 2, 2026 and Feb 2, 2026 — classified as 1 malfunction.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2026Appropriate Device Problem Term/Code Not Available
THE CURRENT CAPS DO NOT ADEQUATELY ABSORB PERSPIRATION, ALLOWING SWEAT TO DRIP INTO THE SURGICAL WOUND, WHICH PRESENTS A QUALITY CONCERN. CUSTOMER INDICATED THE ROOMS ARE HOT IN THE PEDS AREA WHICH IS WHERE ISSUE HAS BEEN REPORTED. ADDITIONAL INCIDENT DETAILS WERE REQUESTED ON (B)(6) 2026, (B)(6) 2026, AND (B)(6) 2026; HOWEVER, NO RESPONSES HAVE BEEN RECEIVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24235031 ↗
Other CAP, SURGICAL devices
- Halyard 69110O&M Halyard, Inc. · CAP, SURGICAL1 recall0 reports
- MEDLINE INDUSTRIES, INC. CRI1004Medline Industries, Inc. · CAP, SURGICAL1 report
- CARDINAL HEALTH 3274Cardinal Health 200, LLC · CAP, SURGICAL1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.