Home / Recalls / Ethicon Endo-Surgery Inc / Z-1271-2019

Z-1271-2019 Class I

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

FDA device recall Z-1271-2019 was initiated by Ethicon Endo-Surgery Inc on April 11, 2019 and is designated Class I. Reason for recall: The staplers may have an insufficient firing stroke to break the washer and completely form staples. Affected quantity: 434,614 total.

Recall Details

Product Type
Devices
Report Date
May 22, 2019
Initiation Date
April 11, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
434,614 total

Product Description

Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

Reason for Recall

The staplers may have an insufficient firing stroke to break the washer and completely form staples.

Distribution Pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Aruba, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt, El Salvador, Guatemala, Honduras, India, Indonesia, Israel, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Malaysia, Maldives, Mexico, Nepal. Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Qatar, Saudi Arabia, Singapore, Sri Lanka, Taiwan, Thailand, UAE, Uruguay, Vietnam, and Yemen.

Code Information

All Lots within EXPIRATION Date Range: February 2023 March 2024

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-0202-2020 Class I — ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE (October 3, 2019)
  • Z-0201-2020 Class I — ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE (October 3, 2019)
  • Z-0200-2020 Class I — ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A (October 3, 2019)

FDA data resources