HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
Check against the official notice below — it lists the full affected range.
Ethicon Endo-Surgery Inc. is recalling 7,870 units of the HARMONIC HD 1000i Shears (20cm Shaft Length) due to a hazard affecting certain lot codes. An internal component in the device may crack and become lodged behind the energy button, potentially causing the device to activate continuously and resulting in burns to users. The affected lot codes are U95126, U9571N, U9526Z, U95A80, U9543P, U95T0X, and U9550G.
The recalled devices were distributed worldwide, including throughout the United States and 40 other countries. The source document does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: Worldwide distribution - US Nationwide distribution and the countries of Austria, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Peru, Philippines, Polan Quantity: 7870 units Lot/code info: Lot Codes: U95126 U9571N U9526Z U95A80 U9543P U95T0X U9550G GTIN: 10705036015048
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.