MEDLINE NEUROSPNG05Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20080196286659), received between Oct 30, 2025 and Jun 15, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 19, 2026Class IIOpen, Classified

   During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

   Z-2008-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Contamination

  IT WAS REPORTED THAT FOLLOWING A 'LEFT LUMBAR 4-LUMBAR 5 MICRODISCECTOMY" ON (B)(6) 2026 WHERE THE NEUROSPONGES WERE USED THE " PATIENT CONTINUES TO HEALING ISSUES. THE CUSTOMER REPORTED "PERSISTANT DRAINAGE , FLUID COLLECTION SUBCONSCIOUSLY AND WOUND OPEN BACK UP" AS WELL AS ERTHIMA ALONG INCISION SITE ".

  Patient problems: Erythema; Fluid Discharge; Impaired Healing; Wound Dehiscence

  MAUDE report 25510241 ↗
• MalfunctionFeb 16, 2026Material Integrity Problem

  COTTONOID DETACHED FROM STRING DURING SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24344979 ↗
• InjuryJan 13, 2026Material Split, Cut or Torn

  ACCORDING TO THE CUSTOMER, (B)(6) 2025 IT WAS DISCOVERED THAT THE STRING WAS MISSING FROM A COTTONOID SPONGE WHILE REMOVING IT FROM THE SURGICAL SITE. THE CUSTOMER SAID "THE STRING HAD BEEN SUCTIONED INTO THE NEPTUNE MACHINE" AND WAS RECOVERED FROM THE NEPTUNE MANIFOLD. THE CUSTOMER CONFIRMED THAT ALL PIECES OF THE COTTONOID WERE RECOVERED AND THE PROCEDURE WAS ABLE TO BE COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24053260 ↗
• MalfunctionDec 16, 2025Detachment of Device or Device Component

  WHILE REMOVING A 1/2 X 1/2 COTTONOID SPONGE FROM THE SURGICAL SITE, THE SCRUB TECH DISCOVERED THE STRING WAS MISSING FROM THE COTTONOID SPONGE. THE SURGICAL TEAM WAS IMMEDIATELY INFORMED. THE SURGICAL AREA WAS INSPECTED, AS WAS THE SURROUNDING AREA. SUSPECTING THE STRING HAD BEEN SUCTIONED INTO THE NEPTUNE MACHINE, THE SUCTION MANIFOLD WAS REMOVED FROM THE MACHINE. THE SUCTION MANIFOLD FILTER HAD CAUGHT THE STRING, AND THE STRING WAS THEN REMOVED FROM THE FILTER. VISUAL CONFIRMATION OF THE STRING WAS COMPLETED BY CIRCULATOR, CTL [CARE TEAM LEADER], AND FELLOW. SURGEON INFORMED. THE PATTY AND STRING WERE OBTAINED, PLACED IN A BIOHAZARD BAG, AND TAKEN TO THE FRONT DESK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815609 ↗
• InjuryOct 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A SPINAL PROCEDURE, A COTTONOID PATTY DETACHED FROM ITS STRING AND MIGRATED INTO THE DURAL SPACE, TRACKING UPWARD APPROXIMATELY TWO SPINAL LEVELS. THIS CAUSED AN INTRAOPERATIVE DELAY OF 1-2 HOURS DUE TO A SEARCH AND RETRIEVAL EFFORT. THE SPONGE WAS LOCATED USING INTRAOPERATIVE O-ARM 3D IMAGING. THE PROCEDURE WAS COMPLETED, BUT REQUIRED EXTENDED ANESTHESIA TIME, INCREASED SURGICAL SITE SIZE, AND ADDITIONAL RADIATION EXPOSURE, ALONG WITH AN OVERNIGHT HOSPITAL STAY INSTEAD OF SAME-DAY DISCHARGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23433246 ↗