FDA Medical devices recall ·
Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton)… recall
- Recall number
- Z-2639-2026
- Date
- (initiated May 7, 2026)
- Company / brand
- Teleflex LLC
3015 Carrington Mill Blvd, Morrisville, NC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1488700
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Pilling¿ Wecksorb Neurosponges (Cotton), 1/2" x 1/2" X-Ray Detectable Catalog Number: 200100 UDI codes: (01)2 4026704 41748 7(17)260521(11)210521(10)21E1485 (01)2 4026704 41748 7(17)260811(11)210811(10)21H2304 (01)2 4026704 41748 7(17)260906(11)210906(10)21H2594 (01)2 4026704 41748 7(17)260906(11)210906(10)21H2595 (01)2 4026704 41748 7(17)261018(11)211018(10)21K3161 (01)2 4026704 41748 7(17)261130(11)211130(10)21L3593 (01)2 4026704 41748 7(17)270203(11)220203(10)22A0175 (01)2 4026704 41748 7(17)270316(11)220316(10)22C0661 (01)2 4026704 41748 7(17)270512(11)220512(10)22E1386 (01)2 4026704 41748 7(17)270915(11)220915(10)22J2777 (01)2 4026704 41748 7(17)271019(11)221019(10)22K3102 (01)2 4026704 41748 7(17)271027(11)221027(10)22K3269 (01)2 4026704 41748 7(17)271031(11)221031(10)22K3270 (01)2 4026704 41748 7(17)280124(11)230124(10)23A0102 (01)2 4026704 41748 7(17)280405(11)230405(10)23D0796 (01)2 4026704 41748 7(17)280426(11)230426(10)23D0900 (01)2 4026704 41748 7(17)280530(11)230530(10)23E1180 (01)2 4026704 41748 7(17)280809(11)230809(10)23H1834 (01)2 4026704 41748 7(17)290319(11)240319(10)24C0647 (01)2 4026704 41748 7(17)290522(11)240522(10)24E1133 (01)2 4026704 41748 7(17)290729(11)240729(10)24G1865 (01)2 4026704 41748 7(17)290731(11)240731(10)24G1864 (01)2 4026704 41748 7(17)291112(11)241112(10)24K2820 Lot/Batch Numbers: 21E1485 21H2304 21H2594 21H2595 21K3161 21L3593 22A0175 22C0661 22E1386 22J2777 22K3102 22K3269 22K3270 23A0102 23D0796 23D0900 23E1180 23H1834 24C0647 24E113
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.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Massachusetts Maryland Maine Michigan Minnesota Missouri Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2639-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.