UltraClean 139104EXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10653405007197), received between Feb 4, 2016 and Jan 22, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 139104EXT ACCESSORY ELECTRODE COATED BLADE WITH EXTENDED INSULATION, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207564 ↗
• MalfunctionFeb 13, 2018Packaging Problem; Packaging Problem

  THE DISTRIBUTOR IN (B)(6) REPORTED A "SCRATCH" ON THE STERILE POUCH OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AS THIS DEFECT WAS DISCOVERED DURING INCOMING INSPECTION. THIS REPORT IS RAISED ON THE BASIS OF A STERILITY BREACH FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 7267916 ↗
• MalfunctionFeb 4, 2016Device Packaging Compromised

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, "INSUFFICIENT HEAT SEAL" WAS FOUND IN THE SEALING AREA OF A STERILE PACKAGE CONTAINING THE ULTRACLEAN 1" COATED BLADE WITH EXTENDED INSULATION. TESTING RESULTS CONFIRMED THAT THE RETURNED PACKAGE EXHIBITING CREASES IN THE FINAL MANUFACTURING SEAL FAILED THE DYE LEAK TEST ON (B)(6) 2016. THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED DEVICE, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: No Patient Involvement

  MAUDE report 5410537 ↗