The Recall Desk
HighFDA (Devices)·Z-2356-2021·Announced 2021-09-01

Surgical Shears HARMONICHD 1000i Recalled Due to Component Defect and Burn Risk

Ethicon is recalling HARMONICHD 1000i Shears due to a cracked internal component that may cause continuous device activation and result in burns. About 68,960 units have been distributed worldwide.

What this means for you

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: FDA Class II recall for a risk-of-harm condition (potential burns from device malfunction). No reported injuries or hospitalizations. Per the rubric, this qualifies as High severity.

Plain-English summary

Ethicon Endo-Surgery Inc is recalling the HARMONICHD 1000i Shears (36cm Shaft Length), a surgical device intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. The recall addresses a potential defect in which an internal component may be cracked.

If the internal component is cracked, it may become lodged behind the energy button, potentially causing continuous device activation. This continuous activation may result in burns.

Approximately 68,960 units with multiple lot codes have been distributed worldwide.

The recalled product

Product
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
Manufacturer
Ethicon Endo-Surgery Inc
Category
Medical Device — Surgical Instruments
Hazard
  • burn-injury
  • cracked-component
  • uncontrolled-activation

Distribution

Distributed nationwide across the United States.

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