Exact Medical recalls 11 lot numbers of 6" x 48" ultrasonic transducer covers due to lack of FDA approval for use in natural or surgical body openings. Consumers should check item ID and lot numbers listed.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling 11 specific lot numbers of ultrasonic transducer covers because they were not approved by the FDA for use in natural or surgical body openings. This means the product could pose a risk if used incorrectly in medical procedures.
The product lacks FDA approval for use in natural or surgical body openings. This means it could cause injury if used during medical procedures where it might be inserted into the body. Without proper approval, the cover may not be safe for medical applications.
Medical professionals using ultrasound equipment during procedures may be affected. Patients undergoing surgery or medical imaging with this cover could be at risk if the cover is used improperly.
Check the item ID (E5322N) and lot numbers listed: 1906E228, 1907E501, 1908E562, 1910E027, 1910E345, 1911E263, 1912E541, 2003E241, 2003E830, 2010E342, 2011E403. These covers are sold for medical use in ultrasound equipment.
Look for item ID E5322N and lot numbers listed in the recall notice to confirm if your cover is affected.
The product lacks FDA approval for use in natural or surgical body openings, which could pose a risk during medical procedures.
Check the item ID and lot numbers listed in the recall notice to see if your cover is affected. If it is, you should stop using it and contact the manufacturer.
The recall notice does not mention a remedy or fix for this product.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1914-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1914-2021 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.
