Exact Medical recalls 6"x96" poly ultrasonic transducer covers with specific lot numbers due to lack of 510k clearance for medical use. Consumers should check their product details.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling certain ultrasonic transducer covers because they lack FDA 510(k) clearance for use in natural or surgical body openings. This means the covers could be unsafe if used medically without proper approval.
The covers were not cleared by the FDA for use in body openings. Without 510(k) approval, they might not be safe for medical procedures, potentially causing harm if used incorrectly.
Users of medical ultrasound devices who have the recalled covers with specific lot numbers are affected. Medical professionals and patients using these covers for procedures are at risk.
Check for the item ID A-AU-0980N and lot numbers: 2003E829, 2003E242, 2004E033, 2005E165, 2005E164, 2005E176, 2005E440, 2011E107, 2011E250, 2101E070, 2012E509.
Identify the lot numbers listed: 2003E829, 2003E242, 2004E033, 2005E165, 2005E164, 2005E176, 2005E440, 2011E107, 2011E250, 2101E070, 2012E509.
The covers lack FDA 510(k) clearance for use in natural or surgical body openings, which could make them unsafe for medical procedures.
Lot numbers: 2003E829, 2003E242, 2004E033, 2005E165, 2005E164, 2005E176, 2005E440, 2011E107, 2011E250, 2101E070, 2012E509.
The recall record does not specify a remedy, so there is no action required beyond checking if your cover has the listed lot numbers.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1911-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1911-2021 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.
