Recall Z-2639-2026 ยท EFQ Gauze/Sponge, Internal
TELEFLEX LLC
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
| Date | Jul 1, 2026 (initiated May 7, 2026) |
| Status | Open, Classified |
| Reason | Due to out-of-specification, or potential out-of-specification, levels of endotoxins |
| Root cause | Device Design |
| 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 th |
| Quantity | 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, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K791871 | NEUROLOGICAL SPONGES (PATTIES) Carwild Corp., Nov 5, 1979 |