SurgiSeal SS-035TRecalls & reported problems

Adhezion Biomedical, LLC · SurgiSeal topical skin adhesive · 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 M495SS035T1), received between Dec 15, 2016 and Dec 15, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Adverse Event Without Identified Device or Use Problem1
Insufficient Device Problem Information1

Patient problems

Hypersensitivity/Allergic reaction1
Rash1

Recent adverse event reports

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

InjuryDec 15, 2016Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
NURSE REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND OOZING AT THE INCISION SITE FIVE DAY AFTER SURGERY. NO OTHER APPLICATIONS WERE KNOWN, BY THE COMPLAINANT, TO BE APPLIED TO THE PATIENT, AND THE PATIENT HAD NO KNOWN ALLERGIES. THE COMPLAINANT DOES NOT KNOW THE LOT NUMBER OF THE MATERIAL, NOR THE SUPPLIER (DISTRIBUTOR) THAT PROVIDED SURGISEAL. THE PATIENT IS RECOVERING.
Patient problems: Hypersensitivity/Allergic reaction; Rash
MAUDE report 6178716 ↗

Device details

UDI-DI	`M495SS035T1`
Brand	SurgiSeal
Model	SS-035T
Company	Adhezion Biomedical, LLC
Product code	MPN · Tissue Adhesive For The Topical Approximation Of Skin
Class	Class 2
FDA submission	K082993
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Skin-approximation adhesive

A sterile biodegradable glue made of synthetic polymer (e.g., cyanoacrylate) intended for topical closure of surgical incisions and simple traumatic lacerations that have easily-approximated skin edges; it is not intended for internal surgical applications. 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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