Floret Neuro Sponge

• 2 recalls, same reason

  • Ongoing Z-2458-2026 FDA Class II ·initiated 8 May 2026
  • Ongoing Z-2459-2026 FDA Class II ·initiated 8 May 2026

  Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

510(k) Number

K830269 ↗

FDA Product Code

EFQ

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Floret Nasal Tampon

  Class I

  FDA 510(k) K830263 Active Cleared 24 Mar 1983

• Isovis Wound Protector

  Class II

  FDA 510(k) K832874 Active Cleared 26 Sep 1983

• Floret Gauze Packing

  Unclassified

  FDA 510(k) K830278 Active Cleared 29 Mar 1983

• Countway Sys. Soiled Sponges-Blood Los

  Class I

  FDA 510(k) K830273 Active Cleared 28 Feb 1983

• Floret Drain/Tracheotomy Sponge

  Unclassified

  FDA 510(k) K830265 Active Cleared 29 Mar 1983

• Floret Foam Prep Sponge

  Class I

  FDA 510(k) K833626 Active Cleared 17 Feb 1984

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