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Avitene Ultrafoam Microfibrillar Collagen Hemostat
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MEDICAL DEVICE RECALLMODERATE

Avitene Ultrafoam Microfibrillar Collagen Hemostat

Davol is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat (Catalog 1050030) due to potential inspect fragment contamination.

What to do

Stop using this product immediately. Contact Davol, Inc. to report any units in your possession and for instructions on return or replacement.

Recalled
Listed
Updated
Recall No.
Z-1896-2026
Agency
FDA
Firm
Davol, Inc.
Recall ID
98602
Status
ONGOING

Recall at a glance

Quantity recalled
1,622 units

Why it was recalled

Davol, Inc. is recalling Avitene Ultrafoam Microfibrillar Collagen Hemostat (Catalog Number 1050030, 8cm x 6.25cm x 1cm) due to potential contamination with inspect fragments. The affected product may contain foreign matter that could pose a risk during surgical use.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.

UDI-DI
00801741010538

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification