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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Exact Medical Manufacturing, Inc.: No 510k for the product to be used in a natural or surgical opening to the body

Agency Publication Date: June 21, 2021
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Affected Products

Product: 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

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
Numbers
Product: Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359

Lot Numbers: 2003E690 2006E079 2004E015 2007E001 2006E079 2007E002 2010E361 2101E329 2011E271

Lot Numbers:
Numbers
Product: Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Transducer Cover Item ID: E6360

Lot Numbers: 2003E691

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
Numbers
Product: Hays Ultrasound kit Item ID: H1000SE

Lot Numbers: 2005E090 2006E495

Lot Numbers:
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Product: Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL

Lot Numbers: 2005E091

Lot Numbers:
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Product: Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17

Lot Numbers: 1909E197 1910E296 1911E050 2002E180 2004E028

Lot Numbers:
Numbers
Product: Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22

Lot Numbers: 2008E475 2009E247 2010E217 2012E102 2012E191

Lot Numbers:
Numbers
Product: Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29

Lot Numbers: 1910E448 2009E249 2009E248 2010E214 2011E249

Lot Numbers:
Numbers
Product: Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576

Lot Numbers: 1909E198 1911E260 2011E248

Lot Numbers:
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Product: Probe Cover, PE, Gel and Elastic bands, 6"x96"-Ultrasonic Transducer Cover Item ID: 1006664

Lot Numbers: 2002E015 2011E316

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
Numbers
Product: 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA

Lot Numbers: 1912E126 2002E133 2008E227 2008E226

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87958
Status: Resolved
Manufacturer: Exact Medical Manufacturing, Inc.
Manufactured In: United States
Units Affected: 18 products (8800 units; 1600 units; 17545 units; 7920 units; 12650 units; 9680 units; 5621 units; 129600 units; 100600 units; 500 units; 51300 units; 10020 units; 3000 units; 78000 units; 33250 units; 36000; 800 units; 6000 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.