DermaCol 100 00300E (UDI 00714196391346)Recalls & reported problems
Sion Brands LLC · Class U
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- 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-1789-2022 · Root cause: Environmental control · FDA record ↗
Other Dressing, Wound, Collagen devices
- Cytal® WSM0505Acell, Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- Cytal® BMM0710Acell, Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- Cytal® WSM0710Acell, Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- PriMatrix® 607-001-125Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- DermaCol 100 00300ESion Brands LLC · Dressing, Wound, Collagen1 recall0 reports
- PriMatrix® 607-004-880Tei Biosciences Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
- GIBSON HEALTHCARE 5251-194Benco Dental Supply CO. · Dressing, Wound, Collagen1 recall0 reports
- Cytal® BMM1015Acell, Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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