MEDLINE INDUSTRIES, LP - Northfield recalls Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters

Devices may have higher than expected amounts of bacterial endotoxin.

Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R

An IMMEDIATE ACTION REQUIRED notification letter dated 2/6/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item numbers and the affected lot numbers listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product, please complete and return the form, as indicated on the response form. When we receive your completed response form you will be sent FedEx return labels to return the product back to Medline ReNewal (if applicable). Your account will receive credit or replacement when the returned product is received. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline ReNewal. If you have any questions, please contact 866-359-1704.

• FDA enforcement recordOfficial FDA database entry for Z-1460-2025
• FDA 510(k) clearance · K221067The device's official FDA premarket clearance record
• FDA device classification · NLHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1220The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find MEDLINE INDUSTRIES, LP - NorthfieldSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.