HarmonicRecalls & reported problems across all models
Ethicon Endo-Surgery, LLC · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Harmonic model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8,752
- Deaths reported
- 6
- Injuries reported
- 122
- Recalls
- 2
We found 13 models of Harmonic by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 8,752 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2017 and Sep 30, 2026 — classified as 6 deaths, 122 injuries, 8,624 malfunctions.
The most frequently reported specific device problem is “Failure to Read Input Signal” (2,863 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Harmonic recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 20, 2021Open, Classified
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
Z-2356-2021 · Root cause: Process control · Recall details · FDA record ↗
- Jul 20, 2021Open, Classified
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
Z-2355-2021 · Root cause: Process control · Recall details · FDA record ↗
Most reported Harmonic problems
Device problems
- Failure to Read Input Signal2,863
- Material Separation2,344
- Detachment of Device or Device Component737
- Device Displays Incorrect Message552
- Break516
- Difficult or Delayed Activation467
- Material Integrity Problem369
- Insufficient Device Problem Information321
Patient problems
- No Clinical Signs, Symptoms or Conditions6,124
- No Consequences Or Impact To Patient2,515
- Hemorrhage/Blood Loss/Bleeding51
- No Code Available22
- Foreign Body In Patient21
- Insufficient Information20
- Burn(s)13
- Blood Loss12
Harmonic models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Harmonic HARHD36Instrument, ultrasonic surgical1 recall2 deaths5,037 reports
- Harmonic HAR1136Instrument, ultrasonic surgical2 deaths1,538 reports
- Harmonic HP054Instrument, ultrasonic surgical793 reports
- Harmonic HARHD20Instrument, ultrasonic surgical1 recall1 death609 reports
- Harmonic HAR1120Instrument, ultrasonic surgical456 reports
- Harmonic HPBLUEInstrument, ultrasonic surgical133 reports
- Harmonic HAR736Instrument, ultrasonic surgical54 reports
- Harmonic HAR17FInstrument, ultrasonic surgical53 reports
- Harmonic HARHPGRInstrument, ultrasonic surgical40 reports
- Harmonic NSLX137SELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)1 death19 reports
- Harmonic HAR745Instrument, ultrasonic surgical9 reports
- Harmonic HAR723Instrument, ultrasonic surgical7 reports
- Harmonic HARHPBLInstrument, ultrasonic surgical4 reports
Recent Harmonic adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Separation; Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950628 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948657 ↗MalfunctionSep 30, 2026Difficult or Delayed Activation
It was reported that during an unknown procedure the device could not be activated. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948444 ↗MalfunctionSep 30, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947893 ↗MalfunctionSep 29, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936108 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935730 ↗MalfunctionSep 29, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934847 ↗MalfunctionSep 29, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933861 ↗MalfunctionSep 29, 2026Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932790 ↗MalfunctionSep 28, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917414 ↗MalfunctionSep 28, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916899 ↗MalfunctionSep 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915938 ↗MalfunctionSep 28, 2026Delivered as Unsterile Product
It was reported that the packaging was open. It was set aside and a new device was used. There was no patient consequence reported. There was a 5 minute delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914140 ↗MalfunctionSep 28, 2026Material Separation
It was reported that during an unknown procedure the titanium tip broke off. The broken piece was retrieved by forceps and was discarded. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913733 ↗MalfunctionSep 28, 2026Failure to Read Input Signal
It was reported that during an unknown procedure there was an issue with the device. It could not be registered by the generator. They tried a different device and there was no issue. No patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913230 ↗
Other Ethicon Endo-Surgery, LLC products
- Harmonic ACE9 models · 12,862 reports
- ECHELON FLEX7 models · 9,393 reports · 1 recall
- ECHELON ENDOPATH31 models · 6,543 reports · 2 recalls
- LIGACLIP26 models · 3,254 reports
- ENDOPATH37 models · 2,785 reports
- ECHELON CIRCULAR4 models · 2,532 reports
- ECHELON Flex ENDOPATH7 models · 2,334 reports
- PROXIMATE41 models · 2,027 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page