N/A (REF ACE14S)Recalls & reported problems
Stryker Sustainability Solutions, Inc. · Ultrasonic Scalpel Curved Shears With Scissor Handle And Hand Control, 15mm active blade length · 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 00885825014766), received between Jan 10, 2017 and Jan 10, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment Of Device Component1
- Device Displays Incorrect Message1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2017Break; Detachment Of Device Component; Device Displays Incorrect Message
IT WAS REPORTED THE HARMONIC SCALPEL CONSOLE ALARMED AND VISUALLY STATED TO REMOVE FROM THE PATIENT. IT WAS REMOVED AND THEN THE MACHINE STATED TO CLEAN THE TIPS. THE TIPS WERE CLEANED WHILE THE SHEERS WERE REMOVED AND A PIECE OF THE SHEERS BROKE OFF WHILE CLEANING. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6239369 ↗
Other Scalpel, ultrasonic, reprocessed devices
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed1 recall94 reports
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed1 recall24 reports
- 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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