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
All models of Avitene (8)
Data updated Oct 16, 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
- 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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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- SURGIFLO® Hemostatic Matrix 2991Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based17 reports
- Avitene 1010090Davol Inc. · Agent, absorbable hemostatic, collagen based7 reports
- Avitene 1010020Davol Inc. · Agent, absorbable hemostatic, collagen based7 reports
- SURGIFLO™ Hemostatic Matrix Kit with Thrombin SF2995Ferrosan Medical Devices A/S · Agent, Absorbable Hemostatic, Collagen Based4 reports
- Avitene 1020010Davol Inc. · Agent, absorbable hemostatic, collagen based3 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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