Pilling Wecksorb Neurosponges Surgical Sponges Recalled for Endotoxin Contamination
Teleflex LLC is recalling Pilling Wecksorb Neurosponges and Neurosponge Strips due to out-of-specification or potentially out-of-specification endotoxin levels. The cotton surgical sponges are used in brain and spine surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of surgical devices used in high-risk procedures (brain and spine surgery) with a serious contamination hazard (endotoxins). Although no reported illnesses or injuries are stated in the source, endotoxin contamination of devices used in the central nervous system presents a significant risk of harm, placing this at severity level 3 per the rubric.
Plain-English summary
Teleflex LLC is recalling multiple catalog numbers of Pilling Wecksorb Neurosponges (Cotton) and Pilling Wecksorb Neurosponge Strips (Cotton). The sponges are made of absorbent cotton material, with some varieties featuring x-ray detectable thread or strings for surgical accountability. These devices are used during cranial and spine surgery to moisten tissue, cushion against bone, and protect brain and central nervous system tissue during surgical procedures.
The recall is due to out-of-specification or potentially out-of-specification levels of endotoxins in the devices. Endotoxins are bacterial contaminants that may pose a risk to patients during surgical use. The affected products were distributed nationwide across the United States and to Panama.
Healthcare facilities and surgical centers that have received these products should stop using them immediately and contact Teleflex LLC for replacement or further instructions. Patients who have undergone surgery with these sponges prior to the recall should consult their healthcare provider if they have any concerns.
For more information, consumers and healthcare professionals can contact the FDA or visit the FDA's medical device database using the recall number Z-2639-2026.
The recalled product
- 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…
- Manufacturer
- TELEFLEX LLC
- Affected units
- 1,488,700
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Pilling¿ Wecksorb Neurosponges (Cotton)
- 481
- 700 Units (US) 7
- 000 Units (PA)
Distribution
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