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Open, Classified

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

FDA Recall Z-2639-2026 · Posted 2026-07-01

Recalling FirmTELEFLEX LLC
Recall StatusOpen, Classified
Product CodeEFQ
Date Initiated2026-05-07
Product Quantity1488700

Reason for Recall

Due to out-of-specification, or potential out-of-specification, levels of endotoxins

Firm Action

On 05/07/2026, the firm sent via email and FedEx an "URGENT MEDICAL DEVICE RECALL" Letter informing customers that firm is recalling Pilling Wecksorb Neurosponge lots due to out-of-specification/potential out-of-specification levels of endotoxin. Medical facilities are instructed: 1. Immediately check inventory, cease use and immediately quarantine affected products. 2. For affected product, mark the applicable checkbox on the Acknowledgement Form and contact Customer Service: a. Fax, including Attn: Customer Service , or email customer service. OR b. Using the online FSN Portal, complete the acknowledgement form virtually using the following link: https://fca.myteleflex.com/en/recall/000596 Note: Option b is only available to customers who received product directly from Teleflex. 3. If no affected product, mark the applicable checkbox on the Acknowledgement Form and return the form to Teleflex. 4. A customer service representative will provide a Return Goods Authorization Number and instructions for the return of products. Teleflex/local dealer will issue a credit note upon receipt of the returned affected product. Distributors 1. Provide copy of recall notice to all customers who received impacted product. Each customers is required to complete the Acknowledgement Form and return it to distributor. 2. Immediately check inventory, cease use and distribution, and immediately quarantine. Return all product in scope. 3. Confirm that field activity have been completed. Forward completed Acknowledgement Form to the e-mail address below. Important - Please ensure only listed batch numbers in scope are listed. Acknowledgement form can be submitted virtually: https://fca.myteleflex.com/en/recall/000596 4. If affected products have been distributed outside of your country, notify Teleflex Customer Service by return email to the email address provided below. For questions - Customer Service 1-866-396-2111, FAX: 1-855-419-8507 Email: [email protected]

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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