Exact Medical recalls Ultrasonic Transducer Cover (Item ID E6360) due to lack of 510k clearance for medical use. Affected units sold with lot number 2003E691.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling an ultrasonic transducer cover because it lacks FDA 510(k) clearance for use in natural or surgical body openings. This means the product could be unsafe for medical procedures.
The product lacks FDA 510(k) clearance, meaning it hasn't been approved for use in body openings. This could lead to improper medical procedures if used without proper regulatory approval.
Medical professionals using this transducer cover for procedures may be affected. Patients undergoing surgery or medical treatments with this device are at risk.
Check for the item ID E6360 and lot number 2003E691 on the transducer cover kit. This product was sold with specific lot numbers for medical use.
Look for item ID E6360 and lot number 2003E691 on the transducer cover kit.
The recall states the product lacks FDA 510(k) clearance for use in body openings, so it is not approved for medical procedures.
The recall does not specify a remedy, so contact Exact Medical directly for guidance.
Check for item ID E6360 and lot number 2003E691 on the transducer cover kit.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1916-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1916-2021 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.
