Brand Name: Checkpoint Guardian Intraoperative Lead recall
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525…
Why was Brand Name: Checkpoint Guardian Intraoperative Lead 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI B13095250 Medium Lot 4322 Expires 01Apr2026 Lot 4326 Expires 01Apr2026 Lot 4333 Expires 01Jul2026 Lot 4352 Expires 01Jul2026
- Product
- Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525…
- Recalling firm
- Checkpoint Surgical Inc
- Quantity
- 452
- Distribution
- US Nationwide distribution.
- Recall date
- April 2, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)