Avitene 1050030Recalls & reported problems
Davol Inc. · Avitene Ultrafoam, 8 cm x 6.25 cm (3-1/8" x 2.5"), 50 sq cm · Class 3 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741010538), received between Dec 17, 2025 and Dec 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
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.
Reports received per month
Recalls naming this device
- Mar 25, 2026Open, Classified
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Z-1896-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
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.
MalfunctionDec 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, AN AVITENE ULTRAFOAM ALLEGEDLY HAD A FOREIGN MATERIAL (SMALL BROWN COLOR) ON THE SURFACE OF THE PRODUCT IN THE INNER STERILE PACKAGE; DISCOVERED PRIOR TO USE. THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS COMPLETELY SEALED BEFORE OPENING. THE ULTRAFOAM WAS NOT USED AND THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829294 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.