Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PIPELINE LS ACCESS SYSTEM Recalled by DePuy Spine, Inc. Due to Dilators and Holding Clip are being used for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Spine, Inc. directly.
Affected Products
PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Quantity: 118 units
Why Was This Recalled?
Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About DePuy Spine, Inc.
DePuy Spine, Inc. has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report