Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CIVCO Biopsy Starter Kit Recalled by Civco Medical Instruments Co. Inc. Due to Sterility of the product cannot be assured.
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 Civco Medical Instruments Co. Inc. directly.
Affected Products
CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 639-016, 639-021, 639-024, 639-025, 639-026, 639-027, 639-033, 639-035, 639-047, 639-051, 658-001, 667-106, 667-106(CMI), 667-127, 672-001, 698-007, 698-009, 698-013, 698-015, 742-397-T, 742-416, and H48392LT. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
Quantity: 1139 boxes
Why Was This Recalled?
Sterility of the product cannot be assured.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Civco Medical Instruments Co. Inc.
Civco Medical Instruments Co. Inc. has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report