Stop using now Medical device recall · FDA · Published April 29, 2021

Exact Medical Hays Ultrasound Kit H1000SE: No FDA Approval for Medical Use

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1918-2021Medical device Exact Medical ›

Stop using this now

No 510k for the product to be used in a natural or surgical opening to the body

Take action

Contact the company

Recalling firmExact Medical Manufacturing, Inc.4917 William St Ste C · Lancaster, NY 14086-3200

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/62636-exact-medical-hays-ultrasound-kit-h1000se-no-fda-approval-for.

Source Summary by GovInfoNow · govinfonow.com/recall/62636-exact-medical-hays-ultrasound-kit-h1000se-no-fda-approval-for · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1918-2021

Cite this page

“Exact Medical Hays Ultrasound Kit H1000SE: No FDA Approval for Medical Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62636-exact-medical-hays-ultrasound-kit-h1000se-no-fda-approval-for. Based on FDA recall #Z-1918-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1918-2021%22&limit=1).

The FDA announced on April 29, 2021, that Exact Medical Manufacturing, Inc. voluntarily recalled Hays Ultrasound kits due to a lack of required 510(k) clearance for use in natural or surgical openings to the body.

How to tell if you have it

Brand: Exact Medical
Product: Hays Ultrasound kit
Item ID: H1000SE
Lot Numbers: 2005E090, 2006E495
Units affected: 10,020

The hazard

The product lacks the necessary 510(k) clearance to be used in a natural or surgical opening to the body, according to the FDA.

Context

GovInfoNow's records show other recent recalls of similar products include Healthmark Mesh Tip Protectors (2026-03-12), MicroPort HIPTURN Fem Head Trial 36mm (2025-12-19), and Medline ARTHROGRAM TRAY and TOL NEURO ANGIO PACK (2026-02-25).

How to tell if you have this one

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.

Brand
Exact Medical
Category
Medical device

FDA recall event · 18 products

All 18 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico

Recall number	Product, codes & lots	Quantity
Z-1907-2021	Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA; Lot Numbers: 1907E366 1908E436 1910E101 1910E444 1912E463 2003E605 2005E438 2008E091 2012E096 2012E103	8800 units
Z-1908-2021	Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA; Lot Numbers: 1908E209 1908E435 2005E171 2007E030	1600 units
Z-1909-2021	6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA; Lot Numbers: 1912E126 2002E133 2008E227 2008E226	17545 units
Z-1910-2021	6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA; Lot Numbers: 1907E386 1911E049 1911E047 1911E261 1912E129 1912E128 2003E604 2003E633 2003E240 2003E932 2003E931 2005E439 2007E257 2010E215 2012E099 2012E506 2101E071	7920 units
Z-1911-2021	Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N; Lot Numbers: 2003E829 2003E242 2004E033 2005E165 2005E164 2005E176 2005E440 2011E107 2011E250 2101E070 2012E509	12650 units
Z-1912-2021	6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N; Lot Numbers: 1912E127 2003E794 2002E132 2003E801 2004E024 2004E514 2009E127 2008E357 2009E467 2009E250 2011E108 2012E100 2012E104	9680 units
Z-1913-2021	Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N; Lot Numbers: 1907E241 1909E199 1908E437 1912E125 2003E828 2005E443 2005E175	5621 units
Z-1914-2021	Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N; Lot Numbers: 1906E228 1907E501 1908E562 1910E027 1910E345 1911E263 1912E541 2003E241 2003E830 2010E342 2011E403	129600 units
Z-1915-2021	Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359; Lot Numbers: 2003E690 2006E079 2004E015 2007E001 2006E079 2007E002 2010E361 2101E329 2011E271	100600 units
Z-1916-2021	Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360; Lot Numbers: 2003E691	500 units
Z-1917-2021	Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N; Lot Numbers: 1906E310 1908E208 1908E561 1910E032 1910E350 1911E262 1912E540 2003E308 2002E135 2003E324 2004E513 2009E129 2009E408 2101E069 2011E404	51300 units
Z-1918-2021	Hays Ultrasound kit Item ID: H1000SE; Lot Numbers: 2005E090 2006E495	10020 units
Z-1919-2021	Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL; Lot Numbers: 2005E091	3000 units
Z-1920-2021	Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17; Lot Numbers: 1909E197 1910E296 1911E050 2002E180 2004E028	78000 units
Z-1921-2021	Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22; Lot Numbers: 2008E475 2009E247 2010E217 2012E102 2012E191	33250 units
Z-1922-2021	Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29; Lot Numbers: 1910E448 2009E249 2009E248 2010E214 2011E249	36000
Z-1923-2021	Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576; Lot Numbers: 1909E198 1911E260 2011E248	800 units
Z-1924-2021	Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664; Lot Numbers: 2002E015 2011E316	6000 units

Based on the official FDA remedy

What to do — step by step

Stop Using It Now
Immediately stop using the Hays Ultrasound kit H1000SE if it was intended for medical procedures on body openings.

Where it went and when

Where it was distributed

Distributed in 5 states and Puerto Rico.

FDA distribution: “US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Georgia, Montana, New York, Ohio, Puerto Rico.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

Apr 29, 2021Firm started the recall
Jun 21, 2021FDA classified it Class II
Jun 30, 2021Published in FDA’s Enforcement Report
May 26, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62636-exact-medical-hays-ultrasound-kit-h1000se-no-fda-approval-for">Exact Medical Hays Ultrasound Kit H1000SE: No FDA Approval for Medical Use (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1918-2021 (April 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1918-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.