EVOTECH™ 50004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705037030958), received between Apr 6, 2021 and Apr 6, 2021 — classified as 1 malfunction.

1 FDA recall record name this device's identifier.

4 other recalls cover devices cleared under the same FDA submission (K082392, K140977, K152189); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 27, 2016Terminated

   Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.

   Z-0965-2017 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionApr 6, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED A CYCLE CANCELLATION OF AN A.10.3 OVERFLOW OR SYSTEM LEAK WITH THEIR EVOTECH¿ ECR AND THE CANCELLED CYCLE WAS RELEASED FOR USE ON PATIENTS PRIOR TO REPROCESSING. THERE IS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION HIGH LEVEL DISINFECTION CANNOT BE ASSURED. THEREFORE, ASP HAS DECIDED TO REPORT ALL INCIDENTS OF LOADS THAT ARE RELEASED FROM CANCELLED CYCLES PRIOR TO REPROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620164 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082392, K140977, K152189. One submission often covers many models, so check the product and lot details in each record.

• Z-1715-2015 · May 11, 2015 · Terminated
  EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for us
• Z-1714-2015 · May 11, 2015 · Terminated
  EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with h
• Z-1150-2013 · Mar 28, 2013 · Terminated
  EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
• Z-1123-2013 · Mar 22, 2013 · Terminated
  EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.