FDA-Device2026-07-08Class IIPROCESSING DEFECT
Pilling Wecksorb Neurosponges surgical sponges recalled for elevated endotoxin levels
What this means
Pilling Wecksorb Neurosponges—sterile cotton sponges used during brain and spine surgery—may contain higher-than-safe levels of endotoxins (bacterial toxins). The affected sponges were manufactured between 2021 and 2024. No injuries have been reported, but elevated endotoxins could trigger an inflammatory response during surgery.
- If you have affected Neurosponges, check the lot number and catalog number against the recall list.
- Do not use recalled sponges in surgical procedures.
- Contact Teleflex or your hospital supply chain to arrange replacement or return.
The agency's original wording
Hazard
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Panama.
Affected count
1488700
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues. Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision. Component: N/A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2639-2026Want us to check the next one for you?
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