The U.S. Food and Drug Administration on Wednesday said shortages of sterile pads, sponges and strips used in neurosurgery may continue through the end of 2026.
The agency added neurosurgical patties, sponges and strips - products used during neurosurgery and microsurgery to absorb fluid and protect delicate tissue - to its list of medical device shortages. The move follows a March recall by manufacturer Medline Industries of neurosurgical patties in its neuro sponge line due to elevated endotoxin levels. The FDA noted that there is no return date set for those products.
According to the FDA, continued use of the affected products could result in health complications that require medical or surgical treatment. The agency specifically cited potential outcomes including fever, inflammation, low blood pressure and nausea.
In response to the disruption, the FDA said it is working with other manufacturers and with healthcare providers to monitor available supplies and to evaluate measures aimed at reducing impacts on patients. As part of its guidance, the FDA has instructed healthcare providers to conserve the affected products when possible and to reserve them for the most critical cases, including brain surgery and procedures where suitable alternatives are not available.
The agency's announcement frames the shortage as an ongoing issue that may persist for an extended period. Providers and manufacturers remain engaged in monitoring and response activities while the recall from March remains unresolved with no resupply date provided.
Context and immediate guidance
The products placed on the shortages list perform specific roles in neurosurgery and microsurgery, primarily absorbing fluids and protecting sensitive tissue during procedures. The FDA's direction to conserve and prioritize use underscores the limited supply and the agency's focus on reserving existing inventory for cases judged most critical by clinical teams.
Agency coordination
The FDA said it is collaborating with other device manufacturers and healthcare institutions to assess supply levels and explore options to limit the patient impact of the shortage. The agency's statement did not provide a timeline for resolution beyond the assessment that disruptions could continue through the end of 2026.
Reporting note - The FDA's notice followed a March recall of specific neurosurgical patties by Medline Industries for elevated endotoxin levels. No return date for those recalled products has been specified.