IontoPatchRecalls & reported problems across all models
LTS Therapy Systems, LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one IontoPatch model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 2 models of IontoPatch by LTS Therapy Systems, LLC in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
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
IontoPatch 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.
- May 22, 2025Open, Classified
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Z-2197-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 22, 2025Open, Classified
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Z-2196-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
IontoPatch models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IontoPatch STATDevice, Iontophoresis, Other Uses1 recall0 reports
- IontoPatch 80Device, Iontophoresis, Other Uses1 recall0 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.
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