The FDA has issued a Class I recall notice of a cloth-like surgical device made by C.R. Bard subsidiary Davol. XenMatrix Surgical Graft is used to treat hernia and abdominal wall repair, notes MassDevice. Class I recalls are the most serious and reserved for damaged or tainted products that could cause serious adverse health consequences or death. The move follows Davol's earlier recall, which alerted healthcare providers to the issue and asked that the product be returned to the company.
The agency says some lots of XenMatrix had elevated levels of endotoxins. "Endotoxins (pyrogens) are substances found in certain bacteria that, at elevated levels, can cause serious illness which can be fatal," the FDA said in its notice.
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Correction: This story has been edited to clarify that Davol issued a recall notice for XenMatrix in January. The FDA posted the Class I recall notice on its website today.