ULTRACLEAN 139112EXT (UDI 20653405034770)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20653405034770), received between Jun 7, 2016 and Feb 13, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2018Packaging Problem; Packaging Problem

  THE DISTRIBUTOR IN (B)(4) REPORTED A "TEAR" ON THE STERILE POUCH OF 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 7268082 ↗
• MalfunctionJun 7, 2016Device Operates Differently Than Expected; Temperature Problem

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, ONE (1) PACKAGE CONTAINING ULTRACLEAN 4" BLADE WITH EXTENDED INSULATION WAS DISCOVERED WITH "INSUFFICIENT HEAT SEAL". THE RETURNED DEVICE EXHIBITED PARTIAL SEAL DISRUPTION IN THE STERILE BARRIER SEAL. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5703023 ↗