Omnigraft™ DFU25251Recalls & reported problems
Integra Lifesciences Corporation · Omnigraft™ Dermal Regeneration Matrix · Class 3
Data updated Oct 18, 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 10381780258872), received between Mar 10, 2022 and Mar 10, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Expiration Date Error” (1 report).
2 other recalls cover devices cleared under the same FDA submission (P900033); they may or may not involve this specific model.
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
- Expiration Date Error1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2022Expiration Date Error; Expiration Date Error
MEDWATCH REPORT NUMBER: (B)(4). A FACILITY REPORTED THAT THE OUTER PACKAGE OF THE OMNIGRAFT DERMAL (DFU25251) HAS DIFFERENT LOT NUMBER AND EXPIRATION DATE THAN THE INNER PACKAGE. OUTER EXPIRATION: 2022-01-05; WHILE INNER EXPIRATION: 2023-06-30.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13722107 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P900033. One submission often covers many models, so check the product and lot details in each record.
- Z-1035-2009 · Jan 16, 2009 · TerminatedIntegra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021
- Z-2328-2008 · Jul 2, 2008 · TerminatedIntegra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA
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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