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Avitene

Davol Inc. · Model 1010110 · UDI-DI 00801741010477

LMF Prescription

510(k) clearances

2,108

Adverse events (92 deaths)

Recalls

Facilities

Description

Avitene Non-Woven Web, 70 mm x 70 mm x 1 mm

Recalls

Date	Firm	Reason
2026-03-25	Davol, Inc.	Potential for product to contain foreign matter, confirmed to be inspect fragments.
2024-04-23	Ethicon, Inc.	Some applicator tips from these lots had open seals.
2023-12-06	Baxter Healthcare Corporation	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ
2023-12-06	Baxter Healthcare Corporation	Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the produ
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2013-03-28	Integra LifeSciences Corporation	Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2013-03-28	Integra LifeSciences Corporation	Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2013-03-28	Integra LifeSciences Corporation	Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2013-03-28	Integra LifeSciences Corporation	Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
2012-10-24	Superstat Corp	The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Super

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.