Exact Medical recalls 6" x 96" Elastic Poly Probe Cover (Item ID A-AU-0853NA) due to lack of 510k clearance for body use. Affected units include specific lot numbers from 2003-2012. No remedy provided in recall notice.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling a specific size of elastic probe cover for ultrasound devices because it lacks FDA 510(k) clearance for use in body openings. This means the product could be unsafe if used during medical procedures involving the body.
The product lacks FDA 510(k) clearance, which is required for medical devices to be safely used in body openings. Without this clearance, the device may not meet safety standards for medical procedures, potentially causing harm during use.
Medical professionals using ultrasound equipment with this specific probe cover are likely affected. Patients undergoing procedures with this cover could be at risk if the product is used without proper clearance.
Check for the product name '6" x 96" Elastic Poly Probe Cover, T Tip, Tele Fold, 3 bands' with the Item ID A-AU-0853NA. Affected units have specific lot numbers listed in the recall notice (e.g., 1907E386, 2003E604).
Identify the product by its name and Item ID A-AU-0853NA to confirm if it matches the recalled items.
The product lacks FDA 510(k) clearance for use in body openings, which means it may not be safe for medical procedures.
Affected lot numbers include 1907E386, 1911E049, 1911E047, 1911E261, 1912E129, 1912E128, 2003E604, 2003E633, 2003E240, 2003E932, 2003E931, 2005E439, 2007E257, 2010E215, 2012E099, 2012E506, 2101E071.
The recall notice does not provide a remedy, so no action is required beyond checking if the product is affected.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1910-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1910-2021 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.
