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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves inadvertent activation of a surgical instrument, which poses a significant risk of injury to patients during procedures, meeting the criteria for a Severe rating.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved (Product Code HAR23). The recall involves 25,657 units that were distributed worldwide, including across the United States and numerous foreign countries.
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 HARMONIC ACE Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired, and can be used in various surgical procedures.
Healthcare providers and facilities should stop using the affected devices and contact Ethicon Endo-Surgery Inc for further instructions on the recall process.
The recalled product
- Product
- HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 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
- 25,657
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)
- P9125C
- P93T5J
- P93T5K
- P93V06
- P93W4Y
- P93Y4A
- P93W8A
- P9400F
- P9409V
- P94A93
- P94A94
- P94C8R
- P94G1W
- P91F4A
- P91F86
- P93M3W
- P93W0A
- P93Z4X
- P93Z96
- P94E6U
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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