Exact Medical recalls ultrasonic transducer covers due to lack of 510k clearance for medical use. Affected items have specific lot numbers and item IDs.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling ultrasonic transducer covers because they were not cleared by the FDA for use in natural or surgical body openings. This means the covers could pose a risk if used incorrectly in medical procedures.
The product lacks FDA 510(k) clearance, meaning it hasn't been approved for use in medical procedures involving body openings. Without this clearance, the covers could cause injury if used in surgical or diagnostic contexts where they might interact with bodily tissues.
Medical professionals using these covers for ultrasound procedures are likely affected. Patients undergoing procedures with these covers may face risks if the covers are not properly cleared for medical use.
Check for lot numbers 1909E198, 1911E260, or 2011E248 on the packaging. The item ID is 1006576 for the ultrasonic transducer cover.
Look for lot numbers 1909E198, 1911E260, or 2011E248 on the packaging.
The product lacks FDA 510(k) clearance for use in natural or surgical body openings, which means it hasn't been approved for medical procedures.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected lot numbers.
Check for lot numbers 1909E198, 1911E260, or 2011E248 on the packaging. The item ID is 1006576 for the ultrasonic transducer cover.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1923-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1923-2021 from Exact Medical. 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.
