Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling Wecksorb Neurosponge Strips (C

FDA device recall Z-2639-2026 · posted 2026-07-01 · Open, Classified

Recall details

Recalling firm

TELEFLEX LLC

Reason for recall

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

Action taken

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: Recalls@teleflex.com

Root cause

Device Design

Status

Open, Classified

Product code

EFQ

Quantity affected

1488700

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,

Date initiated

2026-05-07

Date posted

2026-07-01

Location

Morrisville, NC

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