Agency classClass IIOur severity:High FDA (Devices)·Z-2355-2021·Announced 2021-09-01

HARMONIC HD 1000i Surgical Shears Recalled for Potential Burn Risk

Ethicon is recalling HARMONIC HD 1000i Shears because an internal component may crack and lodge behind the power button, causing continuous unintended activation and potential burns. Affected users should discontinue use immediately.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a surgical device with the potential to cause thermal burns through unintended continuous activation. Although the hazard is significant and risk-of-harm is real, the source text reports no actual injuries, hospitalizations, or deaths, placing it at Score 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ethicon Endo-Surgery Inc is recalling HARMONIC HD 1000i Shears (Product Code: HARHD20) with a 20-centimeter shaft. These are surgical instruments intended for soft tissue incisions when precise bleeding control and minimal thermal injury are desired.

An internal component of the device may become cracked. If this occurs, the cracked component can lodge behind the energy activation button, causing the device to activate continuously without user control.

The recall affects 7,870 units distributed worldwide, including throughout the United States and over 50 countries including Canada, the United Kingdom, Germany, France, Japan, and Australia. The affected lot codes are: U95126, U9571N, U9526Z, U95A80, U9543P, U95T0X, and U9550G.

Continuous unintended activation of this surgical device poses a risk of thermal burns to patients and surgical personnel. Users who have received this product should immediately discontinue use and contact Ethicon for instructions regarding device replacement or return.

The recalled product

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
Manufacturer: Ethicon Endo-Surgery Inc
Category: Medical Device — Surgical Instruments
Hazard: burn-injury
unintended-activation
Affected units: 7,870

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Ethicon Endo-Surgery Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Ethicon Endo-Surgery Inc

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