Exact Medical recalls Hays Ultrasound kit H1000SE (lot 2005E090, 2006E495) due to lack of FDA 510(k) clearance for medical use. Consumers should not use this device for body openings.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling its Hays Ultrasound kit (model H1000SE) because it lacks FDA approval for use in natural or surgical body openings. This means the device could cause harm if used incorrectly for medical purposes.
The device has no FDA 510(k) clearance, meaning it was not approved for use in natural or surgical openings to the body. Using it without proper approval could lead to injury or complications during medical procedures.
Medical professionals and individuals who purchased the Hays Ultrasound kit H1000SE (lot numbers 2005E090 or 2006E495) for medical use. Those using the device on body openings are at highest risk.
Check for the item ID H1000SE on the device. Lot numbers 2005E090 or 2006E495 indicate affected units. This product was sold by Exact Medical Manufacturing, Inc.
Immediately stop using the Hays Ultrasound kit H1000SE if it was intended for medical procedures on body openings.
The recall states the device lacks FDA approval for medical use in body openings, so it is not safe for medical procedures.
The official recall does not specify a remedy, so you should stop using it immediately and contact Exact Medical for further instructions.
Look for the item ID H1000SE and lot numbers 2005E090 or 2006E495 on the device.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1918-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1918-2021 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.
