FDA Recall of Cytal Burn Matrix by Integra LifeSciences

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Integra LifeSciences Corp. is voluntarily recalling 226 units of Cytal Burn Matrix due to an increased rate of out-of-specification endotoxin results, affecting products distributed nationwide in the United States.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 3, 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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Integra LifeSciences Corp. (NeuroSciences) is conducting a voluntary recall of Cytal Burn Matrix because of an increased rate of out-of-specification endotoxin results.

Which Products Are Affected

The affected product is Cytal Burn Matrix 10x15 cm, with Product ID: BMM1015. It includes UDI-DI: 00386190001110 and specific Lot Numbers: 7579681, 7582225, 7582227, 7583933, 7591942, 7591944, 7583935, 7593018, 7594284, and 7593013. A total of 226 units are involved, distributed nationwide in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, and WV.

What You Should Do

Consumers who received the initial notification letter should follow the instructions provided in that letter and contact the recalling firm for further guidance on the affected products.

Why This Matters

This recall addresses potential safety concerns with medical devices, ensuring that products meet necessary specifications to avoid health risks, which is critical for patient safety in healthcare settings.

Source

This information is from the FDA recall with number Z-1820-2026, attributed to the U.S. Food and Drug Administration (FDA).

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Integra LifeSciences Corp. is voluntarily recalling 226 units of Cytal Burn Matrix due to an increased rate of out-of-specification endotoxin results, affecting products distributed nationwide in the United States.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.