Exact Medical recalls 6" x 96" ultrasonic transducer covers with item ID E6443N due to lack of 510k clearance for medical use. Affected units include specific lot numbers.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling ultrasonic transducer covers that were not cleared by the FDA for use in natural or surgical body openings. This means the product could pose a risk if used medically without proper regulatory approval.
The product lacks FDA 510(k) clearance, meaning it was not approved for use in natural or surgical body openings. This could lead to improper medical procedures if used without proper regulatory oversight.
Medical professionals and users who have the specific lot numbers listed in the recall notice are affected. Those using the product for medical procedures without FDA clearance are at higher risk.
Check for the item ID E6443N on the cover. Affected units include lot numbers: 1906E310, 1908E208, 1908E561, 1910E032, 1910E350, 1911E262, 1912E540, 2003E308, 2002E135, 2003E324, 2004E513, 2009E129, 2009E408, 2101E069, 2011E404.
Look for the lot numbers listed in the recall notice to determine if your cover is affected.
The recall states the product lacks FDA 510(k) clearance for medical use, so it is not approved for use in natural or surgical body openings.
The recall does not specify a remedy, so contact Exact Medical directly for guidance.
Check for the item ID E6443N and the specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1917-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1917-2021 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.
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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.
