Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Semi-automatic Biopsy-Needle Recalled by INNOVATIVE TOMOGRAPHY PRODUCT GMBH Due to Sterility Assurance; Coaxial Interventional Needle labeled as sterile...
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 INNOVATIVE TOMOGRAPHY PRODUCT GMBH directly.
Affected Products
Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm); Article no. BIM 16/10, Length 100 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/15, Length 150 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/20, Length 200 mm, Diameter 16 G (1.6 mm); Article no. BIM 14/10, Length 100 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/15, Length 150 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/20, Length 200 mm, Diameter 14 G (2.1 mm) *NOT DISTRIBUTED WITHIN THE US
Quantity: N/A
Why Was This Recalled?
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About INNOVATIVE TOMOGRAPHY PRODUCT GMBH
INNOVATIVE TOMOGRAPHY PRODUCT GMBH has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report