Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 2, 2025
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,
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 electr…
Checkpoint Surgical Inc recalled Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian In… - a moderate-severity action.
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian In… was recalled by Checkpoint Surgical Inc in April 2, 2025. Reason: Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subass…. Check the official notice for the remedy. Verify recall #Z-1467-2025 with the FDA Devices before acting.
The recall
Checkpoint Surgical Inc issued this moderate-severity FDA Devices recall-Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subass….
- Moderate
- severity level
- 452 units
- affected scope
- Class II
- classification
- April 2, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1467-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1467-2025) was formally reported on April 2, 2025, with the manufacturer initiating the action on February 24, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Checkpoint Surgical Inc is listed as the recalling firm, operating out of Cleveland, OH. Federal records list the affected scope as 452.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
452
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1467-2025 |
| Date reported | April 2, 2025 |
| Date initiated | February 24, 2025 |
| Recalling firm | Checkpoint Surgical Inc |
| Firm location | Cleveland, OH |
| Affected scope | 452 |
| Distribution | US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1467-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Checkpoint Surgical Inc. Units affected: 452.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 2, 2025. Severity: Moderate. Recall number: Z-1467-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1467-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 2, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.