Iodosorb Ointment 40g USA 6602125040Recalls & reported problems

Smith & Nephew Medical Limited · Cadexomer Iodine Gel · Class U

Data updated Oct 18, 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 00040565122496), received between Nov 17, 2020 and Nov 17, 2020 — classified as 1 injury.

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 18, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Burning Sensation1

Recent adverse event reports

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

InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CLINIC HAS BEEN USING IODOSORB ON PATIENTS IN THE PAST AND HAVE NOT HAD ISSUES. AS OF RECENTLY, PATIENTS ARE COMPLAINING ABOUT IODOSORB BURNING OR STINGING AND IS UNBEARABLE. CLINIC IS HAVING TO NUMB PATIENTS IN ORDER TO USE OR JUST NOT USE THE PRODUCT AT ALL.
Patient problems: Burning Sensation
MAUDE report 10856868 ↗

Device details

UDI-DI	`00040565122496`
Brand	Iodosorb Ointment 40g USA
Model	6602125040
Company	Smith & Nephew Medical Limited
Product code	FRO · Dressing, Wound, Drug
Class	Class U
FDA submission	K190730
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 7, 2023

Device type (GMDN): Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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