FDA Recall of Avitene Ultrafoam Hemostat Due to Potential Contamination
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,013 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.