FDA Device recall Z-2639-2026
Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catal…
- FDA Device
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catal… by Teleflex, citing due to out-of-specification, or potential out-of-specification, levels of endotoxins.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2639-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-07 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Teleflex |
| Distribution | US |
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
Identifiers
| code_info | Pilling¿ Wecksorb Neurosponges (Cotton), 1/2" x 1/2" X-Ray Detectable Catalog Number: 200100 UDI codes: (01)2 4026704…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)23 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2639-2026%22
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