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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

Ethicon Endo-Surgery Inc: An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns

Agency Publication Date: August 26, 2021
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Affected Products

Product: HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20

Lot Codes: U95126 U9571N U9526Z U95A80 U9543P U95T0X U9550G GTIN: 10705036015048

Lot Numbers:
Codes
Product: HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36

Lot Codes: U94Y9V U95C2A U94Z98 U95427 U9516E U95599 U9503G U95856 U94Y9W U95L0A U9518D U95526 U9507E U9548R U95127 U95525 U9530P U95T2Z U95366 U95R4F U9521Z U95F2T U9554U U95F8W U9564G U95U6A U95524 U95E6F U9512D U95K4D U94Z49 U95F07 U95A9X U95F6N U9569W U95E1U U9571P U95E72 U9587D U95E29 U95815 U95T90 U95814 U95Z67 U95754 U95Y7G U95D4T U9523L U95566 U9530X U9543R GTIN: 10705036015055

Lot Numbers:
Codes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88434
Status: Active
Manufacturer: Ethicon Endo-Surgery Inc
Manufactured In: United States
Units Affected: 2 products (7870 units; 68960 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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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.