Class II U.S. Food and Drug Administration

Teleflex LLC Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb recall: Due to out-of-specification, or potential out-of-specification

Recall published 4 months ago

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

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Due to out-of-specification, or potential out-of-specification, levels of endotoxins

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2639-2026
Published
July 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Teleflex LLC
Product type
Medical devices
Units affected
1488700
Distribution
Nationwide
Made in
United States
Lot / code info
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 24E1133 24G1865 24G1864 24K2820 Pilling¿ Wecksorb Neurosponges (Cotton), 1" x 1" X-Ray Detectable Catalog Number: 200101 UDI codes: (01)2 4026704 41749 4(17)260520(11)210520(10)21E1503 (01)2 4026704 41749 4(17)260531(11)210531(10)21E1546 (01)2 4026704 41749 4(17)260907(11)210907(10)21H2596 (01)2 4026704 41749 4(17)261019(11)211019(10)21K3162 (01)2 4026704 41749 4(17)261130(11)211130(10)21L3594 (01)2 4026704 41749 4(17)270304(11)220304(10)22B0456 (01)2 4026704 41749 4(17)270317(11)220317(10)22C0677 (01)2 4026704 41749 4(17)270506(11)220506(10)22D1299 (01)2 4026704 41749 4(17)271031(11)221031(10)22K3271 (01)2 4026704 41749 4(17)280201(11)230201(10)23A0103 (01)2 4026704 41749 4(17)280602(11)230602(10)23E1235 (01)2 4026704 41749 4(17)280810(11)230810(10)23H1835 (01)2 4026704 41749 4(17)290730(11)240730(10)24G1863 (01)2 4026704 41749 4(17)290821(11)240821(10)24H2070 (01)2 4026704 41749 4(17)291114(11)241114(10)24K2821 Lot/Batch Numbers: 21E1503 21E1546 21H2596 21K3162 21L3594 22B0456 22C0677 22D1299 22K3271 23A0103 23E1235 23H1835 24G1863 24H2070 24K2821 Pilling¿ Wecksorb Neurosponges (Cotton), 1" x 3" X-Ray Detectable Catalog Number: 200102 UDI codes: (01)2 4026704 41750 0(17)260513(11)210513(10)21E1397 (01)2 4026704 41750 0(17)260529(11)210529(10)21E1547 (01)2 4026704 41750 0(17)260907(11)210907(10)21H2597 (01)2 4026704 41750 0(17)261213(11)211213(10)21M3732 (01)2 4026704 41750 0(17)270321(11)220321(10)22C0720 (01)2 4026704 41750 0(17)270509(11)220509(10)22D1297 (01)2 4026704 41750 0(17)270914(11)220914(10)22J2778 (01)2 4026704 41750 0(17)271101(11)221101(10)22K3272 (01)2 4026704 41750 0(17)271103(11)221103(10)22K3273 (01)2 4026704 41750 0(17)280201(11)230201(10)23A0104 (01)2 4026704 41750 0(17)280602(11)230602(10)23E1236 (01)2 4026704 41750 0(17)280913(11)230913(10)23J2156 (01)2 4026704 41750 0(17)290501(11)240501(10)24D0986 (01)2 4026704 41750 0(17)290801(11)240801(10)24G1867 (01)2 4026704 41750 0(17)291031(11)241031(10)24K2761 (01)2 4026704 41750 0(17)291118(11)241118(10)24K2822 Lot/Batch Numbers: 21E1397 21E1547 21H2597 21M3732 22C0720 22D1297 22J2778 22K3272 22K3273 23A0104 23E1236 23J2156 24D0986 24G1867 24K2761 24K2822 Pilling¿ Wecksorb Neurosponges (Cotton), 1/2" x 1 1/2" X-Ray Detectable Catalog Number: 200103 UDI codes: (01)2 4026704 41751 7(17)260514(11)210514(10)21E1398 (01)2 4026704 41751 7(17)260520(11)210520(10)21E1504 (01)2 4026704 41751 7(17)260812(11)210812(10)21H2305 (01)2 4026704 41751 7(17)260909(11)210909(10)21H2599 (01)2 4026704 41751 7(17)2…
UPC codes
200100 200101, 200102 200103, 200104 200105, 200106 200108, 200110 200112, 200120 200121, 200123 200131

Products covered by this recall

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

What to do about Device

Teleflex LLC — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: TELEFLEX LLC — 3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Teleflex LLC medical devices recalled?

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

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Device enforcement record, and contact the company if you are unsure.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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