NA HAR9FR-6Recalls & reported problems
Sterilmed, Inc. · HARMONIC FOCUS+ SHEARS WITH ATT · Class U
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888551045285), received between Sep 20, 2022 and Sep 20, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
Device problems
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A REPROCESSED HARMONIC FOCUS WITH ATT AND AN ISSUE OCCURRED OF FOREIGN MATTER INSIDE PACKAGING. IT WAS REPORTED THAT THERE WAS ONE SMALL GOLD PIECE OF METAL AND ONE SILVER PIECE FLOATING IN THE PACKAGE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. A PICTURE OF THE REPORTED ISSUE WAS PROVIDED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR FOREIGN MATTER INSIDE THE PACKAGING ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15459194 ↗
Other Scalpel, ultrasonic, reprocessed devices
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- MEDLINE HARH36RMedline Industries, Inc. · Single-use reprocessed ultrasonic surgical instruments1 recall24 reports
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed67 reports
- Medline HARH45RMedline Industries, Inc. · Single-use reprocessed ultrasonic surgical instruments1 recall2 reports
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed1 death31 reports
- N/A HAR1136Stryker Sustainability Solutions, Inc. · Single-use reprocessed ultrasonic surgical instruments24 reports
- Medline HAR36MRMedline Industries, Inc. · Scalpel, ultrasonic, reprocessed16 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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