Recall of Cytal Burn Matrix 7x10 cm by Integra LifeSciences

Source: FDA · United States

Integra LifeSciences Corp. is voluntarily recalling 7 units of Cytal Burn Matrix 7x10 cm due to an increased rate of out-of-specification endotoxin results, affecting products distributed nationwide in the US.

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

This notice was issued by FDA on May 4, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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

Integra LifeSciences Corp. (NeuroSciences) is conducting a voluntary recall of Cytal Burn Matrix 7x10 cm because of an increased rate of out-of-specification endotoxin results.

Which Products Are Affected

The affected product is Cytal Burn Matrix 7x10 cm with Product ID: BMM0710. It includes UDI-DI: 00386190001103 and specific Lot Numbers: 7579683, 7579681, 7582227, 7583891, 7594266, 7593018, 7593011, 7593013. A total of 7 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, WV. The recall number is Z-1819-2026.

What You Should Do

Consumers should follow the initial firm notification, which was issued via letter, and contact the recalling firm, Integra LifeSciences Corp., for further instructions regarding the affected products.

Why This Matters

This recall addresses potential quality issues with medical devices, which could impact patient safety by ensuring products meet necessary specifications; it involves a limited number of units in nationwide distribution.

Source

Attribution: FDA. Recall information from FDA records, event ID: 98607.

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 7 units of Cytal Burn Matrix 7x10 cm due to an increased rate of out-of-specification endotoxin results, affecting products distributed nationwide in the US.
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.