Disruptions in Availability of Neurosurgical Patties, Sponges, and Strips - Letter to Health Care Providers

May 6, 2026

The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of neurosurgical patties, sponges and strip devices because of recent supplier issues. The manufacturing disruption in supply of these devices is expected to impact patient care and may require adjustments to the clinical management of patients receiving neurosurgery or microsurgery. The FDA currently expects the duration of this shortage to extend through the end of 2026. The FDA recommends health care providers consider strategies to conserve the use of neurosurgical patties, sponges and strips when possible.  

On March 13, 2026, Medline Industries issued a customer letter stating higher-than-expected endotoxin levels have been identified on Medline branded neurosurgical pattie products, which suggests that out-of-specification endotoxin levels may be present in on-market products. Use of the product may result in health hazards that may necessitate medical or surgical intervention, such as febrile response and/or local transient inflammation, hypotension, or nausea. Medline also updated their neuro sponge product page to state that they have initiated a recall of all SKUs in the Medline Branded neuro sponge category with no definite market re-entry date at this time.

Recommendations

The FDA recommends health care providers experiencing interruptions or shortages in supply of neurosurgical patties, sponges and strips develop strategies to conserve their use. Providers should use their clinical judgment when developing and implementing conservation strategies.  

In developing strategies to preserve the supply for patients at highest risk, please consider the following:

• Prioritize essential clinical use: Reserve neurosurgical patties, sponges and strips, as well as the procedural convenience packs, trays, and kits (kits) containing them for intracranial neurosurgical operations, delicate neural tissue protection where alternatives are unsuitable, and cases requiring high absorbency with minimal linting.
• Implement conservation best practices: Use neurosurgical patties, sponges and strips, and kits containing them, only when necessary, avoid routine or convenience use, open packages only as needed since unused devices cannot be used later, coordinate to minimize redundant use, and consider FDA-authorized alternatives appropriate to the specific surgical application when possible.
• Manage inventory and communication: Monitor daily usage and centralize storage and distribution of bulk and kitted devices, requisition inventory only for essential clinical use, diversify sources of supply for alternatives that are clinically appropriate for specific surgical applications, prioritize neurosurgical cases, avoid stockpiling, and escalate availability or safety concerns to leadership and supply chain teams.  

Background

The FDA has updated the Medical Device Shortages List to include neurosurgical patties, sponges and strips (product code HBA). Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires the FDA to maintain a publicly available, up-to-date list of the devices the FDA has determined to be in shortage.

FDA Actions

The FDA is:

• Working with manufacturers and providers to monitor the current situation to help ensure neurosurgical patties, sponges and strips remain available for patients when medically necessary.
• Evaluating potential solutions for mitigating patient impact.
• Informing the public as new information becomes available.

The FDA reviews each notification received under section 506J of the FD&C Act and uses this information, along with any additional details about the supply of and demand for a device, to determine whether the device is in shortage.

Reporting Problems to the FDA

The FDA encourages health care providers to report any supply chain challenges or suspected adverse events experienced with neurosurgical patties, sponges and strips.

• You can submit information on potential shortages or interruptions in availability to deviceshortages@fda.hhs.gov.
• You can submit voluntary reports through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
• Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

By promptly reporting device availability issues and potential shortages, you can help the FDA understand the scope of the problem and when possible, mitigate the issue.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).