Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer

FDA device recall Z-1319-2026 · posted 2026-02-06 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

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

Action taken

On December 22, 2025, the firm issued Urgent Medical Device Recall letters as a follow-up to an earlier action in 2025 for the same issue, but newly identified item numbers and lots of previously identified item numbers. Notably, the products associated with the new/updated action are to be destroyed by the customer on-site for credit, and not returned to the manufacturer. ***Updated 5/18/26*** The firm issued an expanded notification on 5/15/26 which expanded the action to include on additional lot of product. These devices were not expired at the time of the original notification but have since expired.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NLH

Quantity affected

228

Distribution

Distribution US nationwide.

Date initiated

2025-12-22

Date posted

2026-02-06

Location

Northfield, IL

Related 510(k) clearances