Innovative Tomography recalls sterile biopsy needles (BIM series) due to potential inadequate sterilization. These needles, sold in Europe with CE 0297 marking, may not be sterile and could cause infections if used.
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Innovative Tomography is recalling sterile biopsy needles (BIM series) because they may not have been properly sterilized. Using these needles could lead to infections if they are not sterile. This recall affects medical devices sold in Europe, not the U.S.
The needles are labeled as sterile but may not have been adequately sterilized during manufacturing. This could lead to infections if the needles are used in medical procedures without being properly sterile. The hazard is specific to the manufacturing process and not the use of the device itself.
Medical professionals and patients who use these biopsy needles in Europe. The risk is low as the needles are not distributed in the U.S. and the hazard is about potential contamination rather than immediate injury.
Check for the product name 'Semi-automatic Biopsy-Needle, ITP innotom.com' with CE 0297 marking. Look for article numbers BIM 14/10, BIM 14/15, BIM 14/20, BIM 16/10, BIM 16/15, BIM 16/20, BIM 18/10, BIM 18/15, or BIM 18/20. These needles are only sold in Europe and not distributed in the U.S.
Identify the article number and lot number from the product label to confirm if it is affected.
No, these needles are not distributed within the U.S. and are only available in Europe.
The needles may not have been adequately sterilized, which could lead to infections if used in medical procedures.
The recall does not require immediate action as the needles are not sold in the U.S. and the risk is low. Check the product details to confirm if it is affected.
We’ve drafted a message you can send Innovative Tomography to request your refund or repair — edit it as you like.
Subject: Recall Z-2164-2021 — Innovative Tomography Innovative Tomography Hello, I own a Innovative Tomography that is covered by recall Z-2164-2021 from Innovative Tomography. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
