DermaCol AgRecalls & reported problems across all models
Sion Brands LLC · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one DermaCol Ag model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 3 models of DermaCol Ag by Sion Brands LLC in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Feb 19, 2025 and Feb 19, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
DermaCol Ag recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Z-1796-2022 · Root cause: Environmental control · names 2 of these models · Recall details · FDA record ↗
Most reported DermaCol Ag problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Localized Skin Lesion1
DermaCol Ag models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DermaCol Ag 00502EDressing, Wound, Drug1 recall0 reports
- DermaCol Ag 00502EDressing, Wound, Drug1 recall0 reports
- DermaCol Ag 00503EDressing, Wound, Drug1 report
Recent DermaCol Ag adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE COMPLAINANT USED THE DRESSING ALONG WITH OTHER WOUND CARE SUPPLIES THAT WERE PROVIDED BY MAIL FROM A MEDICAL SUPPLY COMPANY. THE PATIENT USED THE DRESSING IN CONJUNCTION WITH MEDIHONEY AND A ZINC OXIDE PASTE WRAP. HE CLAIMED TO HAVE USED 3-4 DRESSINGS, AND AT A ROUTINE DRESSING CHANGE "2 DAYS LATER" A WORSENING CONDITION OF THE WOUND WAS NOTED. THE PATIENT HAS REPORTED DAILY GRIEVOUS PAIN AND BODILY INJURY WITH USE OF THE PRODUCT; HOWEVER, NO IMAGES OR PHOTOS HAVE BEEN RECEIVED YET BY COVALON AFTER REPEATED ATTEMPTS AT CONTACT AND REQUESTS FOR ADDITIONAL INFORMATION.
Patient problems: Localized Skin Lesion
MAUDE report 21411175 ↗
Other Sion Brands LLC products
All Sion Brands LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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