Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Sp...
FDA Recall #Z-1319-2026 — Class I — December 22, 2025
Product Description
Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710FJ282CRH;
Reason for Recall
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
Recalling Firm
Medline Industries, LP — Northfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
228
Distribution
Distribution US nationwide.
Code Information
BD710DF282CRH UDI-DI 10197344044023 Lots EP250429 EP250808; BD710DF282RRH UDI-DI 10197344044030 Lots EP250429 EP250808; BD710FJ282RRH UDI-DI 10197344044054 Lots EP250429 EP250808; BD710FJ282CRH UDI-DI (case) 40197344044048 (ea) 10197344044047 Lots EP250429 EP250808
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated