Halyard 33736Recalls & reported problems

Avanos Medical, Inc. · HALYARD* INTEGUSEAL* Microbial Sealant IS 100 · Class 2

All models of Halyard (232)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 10680651337365), received between Jun 6, 2023 and Jun 6, 2023 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Eye Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED " BEFORE PACEMAKER IMPLANTATION, CYANOACRYLATE SCATTERED WHEN A DOCTOR SHOOK THE APPLICATOR TO MAKE CYANOACRYLATE EXUDE WELL. THE SCATTERED CYANOACRYLATE CAME INTO THE DOCTOR'S EYE.". THE PHYSICIAN REPORTED FEELING PAIN IN HIS EYE. ADDITIONALLY, HE FOLLOWED-UP WITH AN "EYE DOCTOR SOON AND HAD HIS EYE CLEANED." THE PAIN HAS DIMINISHED.
Patient problems: Eye Pain
MAUDE report 17075423 ↗

Device details

UDI-DI	`10680651337365`
Brand	Halyard
Model	33736
Catalog no.	33736-01
Company	Avanos Medical, Inc.
Product code	NZP · sealant, microbial
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 16, 2018

Device type (GMDN): Surgical skin microbial sealant

A sterile synthetic substance (e.g., cyanoacrylate) intended to be applied to the skin of a patient prior to surgical incision (typically over commonly used preoperative skin preparation and with or without standard surgical draping) to, upon polymerization, bond to the skin and fix microbes, reducing the risk of skin flora contamination during the surgical procedure. It is typically contained within a disposable, ready-to-use applicator. After application, this device cannot be reused.

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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