FDA Adds Neurosurgical Patties and Sponges to Shortage List After Medline Recall

The US Food and Drug Administration has added neurosurgical patties, sponges and strips to its Medical Device Shortages List and told health care providers it expects the disruption to last through the end of 2026, according to a letter to health care providers dated May 6.

The products, listed under FDA product code HBA, are used during neurosurgery and microsurgery to absorb fluid and protect delicate tissue, Medical Design & Outsourcing reported. In its letter, the agency said the interruption stems from "recent supplier issues" and warned that it "is expected to impact patient care and may require adjustments to the clinical management of patients receiving neurosurgery or microsurgery."

Medline recall behind the gap

The FDA pointed to Medline Industries. According to the letter, Medline issued a customer letter on March 13, 2026, stating that higher-than-expected endotoxin levels had been identified on its branded neurosurgical pattie products, which suggested out-of-specification levels may be present in products already on the market. The agency said use of the product may result in health hazards that could require medical or surgical intervention, such as febrile response, local transient inflammation, hypotension or nausea.

Medline has recalled all SKUs in its branded neuro sponge category, the FDA said, citing the company's product page. The FDA categorized the recall as Class 2, Healthcare Dive reported. Medline's website stated: "While we continue to explore alternatives, there is no definite market re-entry date at this time," according to the same report.

Section 506J of the Federal Food, Drug, and Cosmetic Act requires the FDA to keep a public, up-to-date list of devices it has determined to be in shortage. The agency said it reviews each notification it receives under that section, together with other information on supply and demand, to decide whether a device is in shortage.

Conservation steps for hospitals

The FDA recommended that providers facing interruptions develop strategies to conserve the products and said they "should use their clinical judgment when developing and implementing conservation strategies." Its suggestions include reserving the patties, sponges and strips, along with procedural packs, trays and kits that contain them, for intracranial neurosurgical operations, delicate neural tissue protection where alternatives are unsuitable, and cases requiring high absorbency with minimal linting.

The agency also suggested opening packages only as needed, since unused devices cannot be used later, avoiding routine or convenience use, and considering FDA-authorized alternatives suited to the specific surgical application. On inventory, it listed monitoring daily usage, centralizing storage and distribution, diversifying supply sources for clinically appropriate alternatives and avoiding stockpiling.

The American Hospital Association relayed the notice to its members on May 7, summarizing the agency's conservation strategies.

What the FDA says it is doing

The FDA said it is working with manufacturers and providers to monitor the situation so the products remain available when medically necessary, evaluating potential ways to limit the impact on patients, and will inform the public as new information becomes available. It asked providers to report supply chain challenges to its device shortages mailbox and to report suspected adverse events through MedWatch. Device manufacturers and user facilities must still follow the Medical Device Reporting regulations, the letter said.