Exact Medical recalls Lite poly ultrasonic probe covers with specific lot numbers due to lack of FDA approval for use in natural or surgical body openings. Consumers should check their product details.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling certain ultrasonic probe covers because they were not approved by the FDA for use in 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 in medical procedures where it's intended to interact with the body.
Medical professionals using the recalled probe covers for procedures involving body openings. Patients receiving such procedures may be at risk if the cover is used without proper approval.
Check for the item ID A-AU-1002N and lot numbers 1907E241, 1909E199, 1908E437, 1912E125, 2003E828, 2005E443, or 2005E175 on the probe cover.
Look for the item ID A-AU-1002N and specific lot numbers listed in the recall notice.
The product lacks FDA approval for use in natural or surgical body openings, which could pose a risk during medical procedures.
The recall notice does not specify a remedy, so check the product details to see if it matches the recalled items.
The recall indicates the product was not approved for body use, so it could be unsafe even with proper use.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1913-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1913-2021 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.
