Exact Medical Manufacturing recalls Hays Innovation Ultrasound Probe Cover Kit (HS2000HL) due to lack of FDA 510(k) clearance for surgical use. Affected units sold with lot numbers 2005E091.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical Manufacturing recalls their Hays Innovation Ultrasound Probe Cover Kit (HS2:000HL) because it lacks FDA approval for use in medical procedures. This means the cover could be unsafe if used during surgery or other medical openings.
The product lacks FDA 510(k) clearance, meaning it hasn't been approved for use in medical procedures. This could lead to unsafe use during surgeries or other medical openings.
Medical professionals who use ultrasound probes with this cover kit are most at risk. Patients undergoing procedures with this kit may also be affected.
Check for the item ID HS2000HL on the cover kit. Lot numbers 2005E091 were sold with this product.
Look for item ID HS2000HL and lot number 2005E091 on the cover kit.
No FDA 510(k) clearance means it has not been approved for medical use, so it may be unsafe.
The recall record does not specify a remedy, so check with the manufacturer for guidance.
Lot number 2005E091 is affected.
We’ve drafted a message you can send Hays Innovation to request your refund or repair — edit it as you like.
Subject: Recall Z-1919-2021 — Hays Innovation Hays Innovation Hello, I own a Hays Innovation that is covered by recall Z-1919-2021 from Hays Innovation. 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.
