Ethicon HARMONIC ACE Shears Recalled for Inadvertent Activation Risk
Ethicon Endo-Surgery Inc is recalling HARMONIC ACE Shears because an internal component may cause continuous or inadvertent activation of the device.
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: The recall is classified as FDA Class II. The hazard involves a risk of harm (inadvertent activation) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling specific units of the HARMONIC ACE Shears + Adaptive Tissue Technology. The recall involves 146,326 units of the 5mm Diameter / 36cm Length / Curved model (Product Code HAR36). These devices are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
The recall was initiated because the devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device. The agency has classified this recall as Class II.
The devices were distributed worldwide, including nationwide in the United States and to numerous foreign countries. Healthcare providers and facilities should check their inventory for the affected product codes and stop using the recalled devices if they are present.
The recalled product
- Product
- HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal therma
- Manufacturer
- Ethicon Endo-Surgery Inc
- Hazard
- Affected units
- 146,326
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- N93923
- N9392K
- N93978
- P9123A
- P9129W
- P91301
- P91394
- P9139N
- P9144R
- P9149J
- P9148K
- P9168K
- P9173R
- P9174K
- P91795
- P91C51
- P91C83
- P91D30
- P91K68
- P91L0H
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.
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