Halyard 41726Recalls & reported problems
O&M Halyard, Inc. · AEBLUE,SURG,GWNTWL,STERL,XL,1 · Class 2
Data updated Oct 16, 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 10680651417265), received between Sep 13, 2023 and Sep 13, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Compatibility 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Compatibility Problem1
Patient problems
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2023Compatibility Problem; Compatibility Problem
DERMATOLOGIST REPORTS THAT HIS PATIENT HAS A SUSPECTED ALLERGY TO AN INGREDIENT IN SLEEVE AND COLLAR PORTION OF SURGICAL GOWNS. THE PATIENT UTILIZES AERO BLUE PERFORMANCE SURGICAL GOWN (REF # 41726) AND THE AERO CHROME BREATHABLE PERFORMANCE SURGICAL GOWN (REF # 44674). PATIENT HAS A HISTORY OF ALLERGIC CONTACT DERMATITIS TO SEVERAL ALLERGENS, INCLUDING CARBA MIX IN SURGICAL GLOVES. PATIENT PRESENTS WITH RASH ON HANDS AND CENTRAL NECK, THAT WORSENS AFTER SURGICAL DAYS. THESE AREAS ARE TOUCHED BY THE CUFF AND NECKLINE OF THE SURGICAL GOWNS. PATIENT RECEIVES TOPICAL PRESCRIPTION STEROIDS AND OTHER TREATMENTS NOT SPECIFIED.
Patient problems: Rash
MAUDE report 17736727 ↗
Other GOWN, SURGICAL devices
- Medline DYNJP2001SMedline Industries, Inc. · GOWN, SURGICAL2 recalls9 reports
- Medline DYNJP2202SMedline Industries, Inc. · GOWN, SURGICAL2 recalls5 reports
- MEDLINE DYNJP2002SMedline Industries, Inc. · GOWN, SURGICAL2 recalls4 reports
- Medline DYNJP2602Medline Industries, Inc. · GOWN, SURGICAL2 recalls3 reports
- Medline Industries, Inc. DYNJP2402Medline Industries, Inc. · GOWN, SURGICAL2 recalls2 reports
- MEDLINE DYNJP2002Medline Industries, Inc. · GOWN, SURGICAL2 recalls2 reports
- Medline DYNJP2103Medline Industries, Inc. · GOWN, SURGICAL2 recalls1 report
- Medline DYNJP2203Medline Industries, Inc. · GOWN, SURGICAL2 recalls1 report
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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