IontoPatch 80 Iontophoresis Patch Therapy Pads Fail to Absorb Saline Solution
LTS Therapy Systems is recalling the IontoPatch 80 iontophoresis patch because the nonwoven pads do not absorb the saline solution required for proper device operation. Approximately 63,936 units were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device where nonwoven pads fail to absorb saline solution, preventing the device from functioning. Although no illnesses or injuries are reported, a non-functioning therapeutic device constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The FDA is recalling the IontoPatch 80, Model/Catalog Number D-0077-080, an iontophoresis transdermal patch manufactured by LTS Therapy Systems, LLC. Approximately 63,936 units are affected by this recall.
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended for use with the device. This prevents the device from functioning as designed.
The recalled units were distributed in Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota. The affected lot codes are UDI-DI: (01) 10815611020012 with lot numbers 4303-1, 4303-2, and 4303-3.
Consumers should discontinue use of the recalled IontoPatch 80 units and contact LTS Therapy Systems, LLC or their healthcare provider for further guidance.
The recalled product
- Product
- IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
- Manufacturer
- LTS Therapy Systems, LLC
- Hazard
- absorption-failure
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: UDI-DI: (01) 10815611020012 UDI-PI: (10) 4303 Lot numbers: 4303-1
- 4303-2
- 4303-3
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03