Teleflex Llc: Gauze/sponge, Internal
Teleflex LLC is recalling certain Pilling Wecksorb Neurosponges—absorbent cotton sponges used during brain and spine surgery to protect tissue and cushion against bone—because they may contain higher-than-acceptable levels of endotoxins, which are bacterial contaminants. The affected products were distributed nationwide across the U.S. and to Panama. This recall affects medical facilities and surgical centers that may have these sponges in stock.
- Recalling firm
- TELEFLEX LLC
- Product
- 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...
- Reason
- Due to out-of-specification, or potential out-of-specification, levels of endotoxins
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-07
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/81779594-c719-454e-ab02-df98bb47c794