Pilling Wecksorb Cylindrical Sponges recalled due to compromised sterility
TELEFLEX LLC recalled 1,000 units of Pilling Wecksorb Cylindrical Sponges (Lot 22B0395) because certain lots were not irradiated to eliminate pyronema, potentially compromising sterility. No illnesses have been reported.
What this means for you
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 medical device recall with no reported hospitalizations or injuries. The hazard—compromised sterility due to inadequate irradiation—represents a risk-of-harm product where injury has not yet been reported, which per the severity rubric classifies as High.
Plain-English summary
TELEFLEX LLC is recalling 1,000 units of Pilling Wecksorb Cylindrical Sponges due to a sterilization defect. Catalog Number 200400, Lot Number 22B0395 were not irradiated to eliminate pyronema, which may compromise the sterility of the affected products.
The affected sponges were distributed domestically to Illinois, Mississippi, Pennsylvania, and Tennessee. Customers who have received the affected product should contact TELEFLEX LLC or their healthcare provider for instructions on how to proceed. Healthcare facilities should review their inventory for the affected lot number and take appropriate action to prevent use of potentially non-sterile products.
The recalled product
- Product
- Pilling Wecksorb Cylindrical Sponges
- Manufacturer
- TELEFLEX LLC
- Hazard
- sterilization-failure
- contamination
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 (2)
- Catalog Number: 200400
- Lot Number: 22B0395
Distribution
Distributed in 4 states:
- IL
- MS
- PA
- TN
Related recalls
Same category
- HighSurgify Halo surgical drill recalled for potential burr breakage
FDA (Devices) · 2026-07-01
- SevereMedline convenience kits recalled for unapproved syringe design changes
FDA (Devices) · 2026-07-01
- HighMedline Industries Polycarbonate Syringes Convenience Kits Design Change Recall
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- SevereMedline Convenience Kits with Lidocaine and Bupivacaine Injections Recalled
FDA (Devices) · 2026-07-01