Exact Medical recalls bulk ultrasonic transducer covers due to lack of 510k clearance for body use. Affected items have specific lot numbers. Consumers should contact Exact Medical for details.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling bulk ultrasonic transducer covers that lack FDA 510(k) clearance for use in natural or surgical body openings. This means the covers could pose a risk if used in medical procedures requiring body access.
The product lacks FDA 510(k) clearance, meaning it hasn't been approved for use in natural or surgical body openings. This could lead to complications if the cover is used in medical procedures where body access is required.
Medical professionals using these covers during procedures involving body openings may be affected. Patients undergoing surgery with these covers could also be at risk.
Check for lot numbers: 1907E366, 1908E436, 1910E101, 1910E444, 1912E463, 2003E605, 2005E438, 2008E091, 2012E096, or 2012E103. The product is a 6" x 48" regular PE cover with two elastic bands.
Look for lot numbers on the cover: 1907E366, 1908E436, 1910E101, 1910E444, 1912E463, 2003E605, 2005E438, 2008E091, 2012E096, or 2012E103.
The recall states the product lacks FDA 510(k) clearance for use in natural or surgical body openings, so it is not approved for medical procedures requiring body access.
The recall does not specify a remedy, so contact Exact Medical directly for instructions.
Check for lot numbers: 1907E366, 1908E436, 1910E101, 1910E444, 1912E463, 2003E605, 2005E438, 2008E091, 2012E096, or 2012E103. The product is a 6" x 48" regular PE cover with two elastic bands.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1907-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1907-2021 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.
