Recall Z-2639-2026— TELEFLEX LLC

Name: FDA recall Z-2639-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-07

Class II · Ongoing

Class II FDA medical device recall by TELEFLEX LLC, initiated 2026-05-07. It names one FDA 510(k) clearance: K791871. 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 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. Reason: Due to out-of-specification, or potential out-of-specification, levels of endotoxins.

Recalling firm: TELEFLEX LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-05-07
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K791871 — NEUROLOGICAL SPONGES (PATTIES)Carwild Corp.·cleared 1979-11-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.