Checkpoint Surgical Inc recalls Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian…

Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.

The recalling firm alerted affected hospitals by visit on February 24, 2025. Customers were asked to check inventory for affected lot numbers and to return the affected inventory for replacement. Notifications were issued on February 26, 2025.

• FDA enforcement recordOfficial FDA database entry for Z-1467-2025
• FDA 510(k) clearance · K212355The device's official FDA premarket clearance record
• FDA device classification · ETNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 874.1820The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Checkpoint Surgical IncSearch 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.