Home / Recalls / Ethicon Endo-Surgery Inc / Z-2048-2018

Z-2048-2018 Class II Terminated

Recalled by Ethicon Endo-Surgery Inc — Blue Ash, OH

Recall Details

Product Type
Devices
Report Date
June 6, 2018
Initiation Date
May 3, 2018
Termination Date
November 25, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25657

Product Description

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 thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Reason for Recall

The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

Distribution Pattern

Worldwide distribution - US Nationwide. The devices were distributed to the following foreign countries: Algeria, Angola, Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, UK, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mayotte, Mexico, Mongolia, Montenegro, Morocco, Netherlands, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, UAE, Uruguay, Vietnam.

Code Information

P9125C, P93T5J, P93T5K, P93V06, P93W4Y, P93Y4A, P93W8A, P9400F, P9409V, P94A93, P94A94, P94C8R, P94G1W, P91F4A, P91F86, P93M3W, P93W0A, P93Z4X, P93Z96, P94E6U, P94H32, P94H9V, P94J28

Other recalls by Ethicon Endo-Surgery Inc

  • Z-0147-2026 Class II — ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, a (September 11, 2025)
  • Z-1746-2025 Class I — Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); (April 22, 2025)
  • Z-0834-2024 Class II — ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON E (December 11, 2023)
  • Z-2355-2021 Class II — HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions (July 20, 2021)
  • Z-2356-2021 Class II — HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions (July 20, 2021)
  • Z-2326-2021 Class II — ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or cr (June 3, 2021)
  • Z-0656-2020 Class II — Ligamax 5 mm Endoscopic Multiple Clip Applier (November 7, 2019)
  • Z-0200-2020 Class I — ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A (October 3, 2019)
  • Z-0201-2020 Class I — ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE (October 3, 2019)
  • Z-0202-2020 Class I — ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE (October 3, 2019)