Recall of Cytal Wound Matrix 2-Layer Issued by Integra LifeSciences
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Integra LifeSciences Corp. is recalling 148 units of Cytal Wound Matrix 2-Layer 5x5 cm due to increased rates 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 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 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.
Recall of Cytal Wound Matrix 2-Layer
What Happened
Integra LifeSciences Corp. is initiating a voluntary recall of its Cytal Wound Matrix 2-Layer 5x5 cm due to an increased rate of out-of-specification endotoxin results.
Which Products Are Affected
The affected product is Cytal Wound Matrix 2-Layer 5x5 cm, with Product ID: WSM0505. A total of 148 units are involved, distributed in the US nationwide, specifically 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. The lot numbers are 7579683, 7583933, 7583891, 7583935, 7594266, 7594286, and 7593011. The UDI-DI is 00386190001431, and the recall number is Z-1816-2026.
What You Should Do
Consumers who have the affected product should follow the initial firm notification, which is a letter from Integra LifeSciences Corp., for instructions on the recall.
Why This Matters
This recall highlights potential safety concerns with medical devices, as it involves 148 units that could have endotoxin issues, impacting distribution across multiple US states.
Source
This information is from the FDA, recall number Z-1816-2026, event ID 98607.
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 (1,208 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.