FDA Recall of Avitene Ultrafoam Hemostat Due to Potential Contamination
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Davol, Inc. is voluntarily recalling 1,622 units of Avitene Ultrafoam Microfibrillar Collagen Hemostat because of potential insect fragments in the product.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
The recall is due to the potential for the product to contain foreign matter, confirmed to be insect fragments.
Which Products Are Affected
The affected product is Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm, with Catalog Number: 1050030. A total of 1,622 units are involved, with Lot Number: WBJS0055 and expiration date of July 28, 2027. The product has UDI: (01)00801741010538(17)270728(10)WBJS0055, and distribution includes US nationwide as well as China and South Korea.
What You Should Do
Consumers who have the affected product should contact the recalling firm, Davol, Inc., through their initial notification methods, which include email, fax, letter, press release, telephone, or visit, for further instructions on returns or refunds.
Why This Matters
This recall highlights potential safety issues with medical devices that could affect patient health, involving over 1,600 units distributed worldwide.
Source
FDA recall notice Z-1896-2026.
Original source: FDA Official Notice ↗
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