The U.S. Food and Drug Administration on Wednesday confirmed ongoing supply disruptions involving specific sterile pads, sponges and strips used in neurosurgery and microsurgery, and cautioned that the shortage could persist through the end of 2026.
The FDA said it has added neurosurgical patties, sponges and strips - products intended to absorb fluids and protect delicate tissue during neurosurgical and microsurgical procedures - to its medical device shortages list.
In March, Medline Industries recalled neurosurgical patties from its neuro sponge line after detecting elevated endotoxin levels. The FDA noted the recalled products currently have no return date set.
According to the agency, use of the affected items could lead to health problems that may require medical or surgical treatment. The FDA listed potential clinical issues including fever, inflammation, low blood pressure and nausea.
The agency said it is coordinating with other manufacturers and healthcare providers to monitor existing inventories and to evaluate strategies that could lessen the impact on patients. As part of its guidance, the FDA has instructed healthcare providers to conserve the affected products whenever feasible and to reserve them for the most critical cases, specifically citing brain surgery and procedures where acceptable alternatives are not available.
Healthcare service provider Premier commented on the recall and the affected products, saying the recalled items are specialized for brain and spine surgeries. "This is a high-risk low-frequency product," said Karen Niven, senior director of clinical value analysis at Premier. "We have advised our members to first look at conservation."
Taken together, the FDA's designation, the March recall by Medline and the absence of a resupply date create a constrained supply environment for specialized neurosurgical supplies. The agency's conservation guidance and its work with manufacturers and providers aim to prioritize the availability of the remaining units for cases where no alternatives exist.
Because the items are used in delicate neurosurgical and microsurgical operations, the FDA and clinical stakeholders emphasize targeted preservation of current stocks and close monitoring of patient safety signals. The shortage notice makes clear that affected products present both supply-chain and clinical risks until production and distribution return to routine levels.