Exact Medical recalls ultrasonic transducer covers with item ID SH22 due to lack of 510k clearance for medical use. Affected units include specific lot numbers from 2008-2012.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling ultrasonic transducer covers (item ID SH22) because they were not cleared by the FDA for use in natural or surgical body openings. This means the product could cause injury if used medically.
The product lacks FDA 510(k) clearance, meaning it was not tested or approved for use in body openings. This could lead to injury if used in medical procedures without proper safety validation.
Medical professionals who use these covers during procedures may be affected. Patients using the covers for medical purposes are at risk of injury.
Check for item ID SH22 on the cover. Affected units have lot numbers: 2008E475, 2009E247, 2010E217, 2012E102, or 2012E191.
Look for item ID SH22 and the listed lot numbers on the cover.
The product lacks FDA 510(k) clearance for use in natural or surgical body openings, which could cause injury.
Check for item ID SH22 and lot numbers listed. If you have the affected units, stop using them immediately.
Yes, the product was not cleared for medical use, so it could cause injury if used in body openings.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1921-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1921-2021 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.
