FDA warns neurosurgical sponge shortage could last through 2026

Hospitals that rely on tiny neurosurgical pads, sponges and strips are being warned to conserve them now, because the shortage can reach the operating room before a replacement does. The U.S. Food and Drug Administration said the disruption may force changes in the clinical management of neurosurgery and microsurgery patients, especially in delicate brain, spine and other procedures where these disposable materials absorb fluid and protect sensitive tissue.

On Wednesday, May 6, 2026, the agency added neurosurgical patties, sponges and strip devices to its medical device shortages list under product code HBA, the FDA category for neurosurgical patties. The list is meant to give hospitals and suppliers an early signal that a device category is in short supply, even though a listing does not necessarily mean patient care has already been affected. In this case, the agency said the shortage could continue through the end of 2026.

The immediate pressure comes from Medline Industries, LP. The company’s neuro sponge recall began on March 19, 2026 and was posted by the FDA on April 30, 2026 after reports of elevated endotoxin levels. FDA recall records show the action touched multiple procedure kits, including ENT, epistaxis, rhino, sinus, septo, nasal, stereotactic, spine, bronchoscopy and airway-related kits. Health Canada updated its own recall notice on April 9, 2026, saying certain Medline neuro sponge items and lots were being pulled because of a potential out-of-specification endotoxin problem and advising customers to destroy the products.

The FDA said use of affected products could lead to fever, inflammation, low blood pressure or nausea, making this more than a supply problem. The agency said it is working with other manufacturers and health care providers to monitor supply and blunt the impact on patients, while advising providers to conserve the products when possible, open packages only when needed, diversify supply sources and reserve the devices for the most critical cases, including brain surgery and procedures where alternatives are not suitable.

The shortage also exposes how concentrated the market is. FDA product-code records show HBA covers neurosurgical patties, and 510(k) records include Medline Neuro Sponge and Codman Surgical Patties & Strips, underscoring that only a small number of specialized suppliers serve this corner of surgery. For hospitals, the practical risk is a forced reordering of cases, with the most vulnerable patients found in neurosurgery, microsurgery and specialty procedures that depend on highly specific disposable materials.