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CONTOURRecalls & reported problems across all models

Ethicon Endo-Surgery, LLC · 4 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
871
Deaths reported
2
Injuries reported
120
Recalls
0

We found 4 models of CONTOUR by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 871 adverse event reports in the FDA's MAUDE database, received between Nov 28, 2017 and Jun 25, 2026 — classified as 2 deaths, 120 injuries, 749 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (281 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 7 reportsDec 2023: 10 reportsJan 2024: 8 reportsFeb 2024: 11 reportsMar 2024: 1 reportsApr 2024: 4 reportsMay 2024: 2 reportsJun 2024: 5 reportsJul 2024: 3 reportsAug 2024: 4 reportsSep 2024: 7 reportsOct 2024: 6 reportsNov 2024: 3 reportsDec 2024: 8 reportsJan 2025: 3 reportsFeb 2025: 6 reportsMar 2025: 2 reportsApr 2025: 2 reportsMay 2025: 2 reportsJun 2025: 2 reportsJul 2025: 1 reportsAug 2025: 2 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 2 reportsDec 2025: 3 reportsJan 2026: 5 reportsFeb 2026: 2 reportsMar 2026: 1 reportsApr 2026: 1 reportsMay 2026: 3 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202611
Last 36 months. The most recent month may be incomplete.

Most reported CONTOUR problems

Device problems

  • Failure to Form Staple281
  • Failure to Fire253
  • Difficult to Open or Close103
  • Material Integrity Problem65
  • Failure to Cut48
  • Adverse Event Without Identified Device or Use Problem39
  • Insufficient Device Problem Information38
  • Break28

Patient problems

  • No Clinical Signs, Symptoms or Conditions385
  • No Consequences Or Impact To Patient378
  • No Code Available50
  • Failure to Anastomose38
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available15
  • Insufficient Information15
  • Unspecified Tissue Injury12
  • Hemorrhage/Blood Loss/Bleeding5

CONTOUR models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent CONTOUR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Ethicon Endo-Surgery, LLC products

All Ethicon Endo-Surgery, LLC devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page