ENDOTRAC 3056-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327364170), received between Oct 31, 2023 and Oct 31, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

13 other recalls cover devices cleared under the same FDA submission (K940230); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SURGEON WAS USING AN EPF KIT. WHEN THEY PUSHED Q-TIP THROUGH, THERE WAS SOME BLACK RESIDUE ON THE Q-TIP. THIS RESULTED IN THE PATIENT HAVING AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18041853 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K940230. One submission often covers many models, so check the product and lot details in each record.

• Z-2418-2019 · Jul 25, 2019 · Terminated
  Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique
• Z-2422-2019 · Jul 25, 2019 · Terminated
  Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgic
• Z-2412-2019 · Jul 25, 2019 · Terminated
  Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for c
• Z-2419-2019 · Jul 25, 2019 · Terminated
  Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for c
• Z-2415-2019 · Jul 25, 2019 · Terminated
  Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for
• Z-2416-2019 · Jul 25, 2019 · Terminated
  Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique
• Z-2424-2019 · Jul 25, 2019 · Terminated
  Endintrak 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical techni
• Z-2417-2019 · Jul 25, 2019 · Terminated
  Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical techni
• Z-2414-2019 · Jul 25, 2019 · Terminated
  Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique
• Z-2413-2019 · Jul 25, 2019 · Terminated
  Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for
• Z-2423-2019 · Jul 25, 2019 · Terminated
  Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical t
• Z-2421-2019 · Jul 25, 2019 · Terminated
  Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical tech
• Z-2420-2019 · Jul 25, 2019 · Terminated
  Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical