Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set Recalled by Cook Medical Incorporated Due to MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy...
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 Cook Medical Incorporated directly.
Affected Products
Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is intended for percutaneous acquisition of soft tissue specimens for laboratory analysis.
Quantity: 1239 units
Why Was This Recalled?
MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these products. The recall has been initiated due to customer complaints that the protective caps were dislodged in the pouch. Further investigation disclosed potential dislodging of protective caps on the needle tips on other distributed products.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cook Medical Incorporated
Cook Medical Incorporated has 53 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report