Brand Name: Checkpoint Guardian Intraoperative Lead Product Name:… — Class II medical device recall Z-1467-2025
Ongoing recall by Checkpoint Surgical Inc, reported 2025-04-02, distributed nationwide. Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subasse
| Recall number | Z-1467-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Checkpoint Surgical Inc, Cleveland, OH, United States |
| Recall initiated | 2025-02-24 |
| Classified | 2025-03-26 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Quantity | 452 |
| Reason classes | packaging |
| Lot numbers | 4322, 4326, 4333, 4352 |
| Model numbers | 9525 |
| Expiration dates | 2026-04-01, 2026-07-01 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1467-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.