Exact Medical recalls 6" x 96" ultrasonic transducer covers with no 510k clearance for surgical use. Affected items 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 6" x 96" ultrasonic transducer covers that lack FDA 510(k) clearance for surgical use. This means the product may not be safe for medical procedures without proper regulatory approval.
The product lacks FDA 510(k) clearance, meaning it has not been approved for use in surgical openings to the body. This could lead to unsafe medical procedures if used without proper regulatory oversight.
Medical professionals using the product for surgical procedures are most at risk. Patients undergoing surgery with this cover could face safety issues due to lack of regulatory approval.
Check for the item ID A-AU-0778NA and lot numbers 1908E209, 1908E435, 2005E171, or 2007E030 on the product packaging.
Look for the item ID A-AU-0778NA and specific lot numbers on the packaging.
The recall states the product lacks FDA 510(k) clearance for surgical use, so it is not approved for medical procedures.
Lot numbers 1908E209, 1908E435, 2005E171, and 2007E030 are affected.
The recall record does not specify a remedy or replacement process.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1908-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1908-2021 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.
