Z-1467-2025Class II

Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead...

Name: Z-1467-2025 Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead...
Creator: Checkpoint Surgical Inc
Published: 2025-02-24
License: https://open.fda.gov/license/

Checkpoint Surgical Inc / initiated 2025-02-24 / Open, Classified / root cause: manufacturing process

FDA source

Checkpoint Surgical Inc began a recall of Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium)... on 2025-02-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1467-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-24
Posted: 2025-03-26
Recalling firm: Checkpoint Surgical Inc
Product: Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing stimulus to a targeted nerve. The accessories are intended for use with any device from the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a targeted nerve.
Product code: ETN Stimulator, Nerve
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 452
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI B13095250 Medium Lot 4322 Expires 01Apr2026 Lot 4326 Expires 01Apr2026 Lot 4333 Expires 01Jul2026 Lot 4352 Expires 01Jul2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1467-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1466-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-26
Z-1467-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-02	2025-03-26

Product code ETN

K212355Class IICheckpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, LargeCheckpoint Surgical / cleared 2021-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)