Exact Medical recalls 6" x 48" Elastic Poly Probe Covers due to lack of 510k clearance for surgical use. Affected items include specific lot numbers and item IDs. Consumers should contact Exact Medical for details.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling 6" x 48" Elastic Poly Probe Covers because they lack FDA 510k clearance for use in natural or surgical body openings. This means the product could pose a risk if used medically without proper regulatory approval.
The product lacks FDA 510k clearance, which is required for medical devices used in body openings. Without this clearance, the device may not be safe for surgical or medical use, potentially causing harm if used improperly.
Medical professionals and users who have the specific lot numbers listed in the recall may be affected. Those using the product for surgical procedures without proper clearance are at higher risk.
Check for the item ID A-AU-10-058N and lot numbers listed: 1912E127, 2003E794, 2002E132, 2003E801, 2004E024, 2004E514, 2009E127, 2008E357, 2009E467, 2009E250, 2011E108, 2012E100, 2012E104.
Look for the item ID A-AU-10-058N on the product.
Reach out to Exact Medical Manufacturing, Inc. for specific instructions on handling affected items.
The product lacks FDA 510k clearance for use in natural or surgical body openings, which is required for medical devices.
Lot numbers include 1912E127, 2003E794, 2002E132, 2003E801, 2004E024, 2004E514, 2009E127, 2008E357, 2009E467, 2009E250, 2011E108, 2012E100, 2012E104.
The recall does not specify a stop-use instruction, so users should contact Exact Medical for guidance.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1912-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1912-2021 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.
