Ethicon recalls Harmonic HD 1000i Shears (20cm shaft) due to potential internal component cracking causing continuous activation and burns. Affected units have specific product codes and lot numbers.
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
Ethicon is recalling Harmonic HD 1000i Shears with a 20cm shaft length because an internal component may crack and get stuck behind the energy button. This could cause the device to activate continuously, leading to burns. Affected units have specific product codes and lot numbers listed in the recall.
An internal component can crack and become lodged behind the energy button, causing the device to activate continuously. This continuous activation may result in burns to the user or patient.
Medical professionals using the shears for soft tissue incisions are most at risk. The recall affects specific units sold with product codes starting with HARHD20 and certain lot numbers.
Check for product code HARHD20 and lot numbers U95126, U9571N, U9526Z, U95A80, U9543P, U95T0X, or U9550G. The shears are intended for soft tissue incisions when bleeding control and minimal thermal injury are desired.
Verify your shears have product code HARHD20 and one of the listed lot numbers: U95126, U9571N, U9526Z, U95A80, U9543P, U95T0X, or U9550G.
An internal component may crack and become lodged behind the energy button, causing continuous activation and potential burns.
Check for product code HARHD20 and lot numbers U95126, U9571N, U9526Z, U95A80, U9543P, U95T0X, or U9550G.
The recall does not specify a remedy, so contact Ethicon Endo-Surgery Inc for guidance.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2355-2021 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2355-2021 from Ethicon. 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.
