Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spine Wave Access Kit Recalled by Spine Wave, Inc. Due to Mislabeling
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 Spine Wave, Inc. directly.
Affected Products
Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. Product Usage: The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three sterile disposable dilators (individually packaged by Spine Wave). The Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
Quantity: 121 units
Why Was This Recalled?
Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Spine Wave, Inc.
Spine Wave, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report