TENS Devices Recalled for Missing Instruction Manual Warnings
Liberty Medical Solutions is recalling 473 Multi-Mode TENS stimulator units distributed in five states due to missing warnings and contraindications in instruction manuals.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device recall involving incomplete labeling (missing warnings and contraindications). No illnesses or injuries have been reported. A labeling deficiency without reported harm meets the criteria for Moderate severity.
Plain-English summary
Liberty Medical Solutions, LLC is recalling 473 Multi-Mode Stimulator units designed for Transcutaneous Electrical Nerve Stimulation (TENS). The recalled units were distributed in Connecticut, Florida, North Carolina, New Jersey, and New York between 2018 and 2023.
The instruction manuals included with these devices do not contain all appropriate warnings and contraindications. This labeling deficiency means users may lack critical safety information needed for proper use.
The FDA assigned this recall the identification number Z-0506-2024. Additional details, including specific serial numbers of affected devices, are available through the FDA website.
The recalled product
- Product
- Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
- Manufacturer
- Liberty Medical Solutions, LLC
- Affected units
- 473
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 (20)
- UDI/DI 00860000178303
- Serial Numbers: 181102627
- 180101759
- 180302368
- 180603258
- 180101748
- 180603502
- 160700386
- 170305821
- 170305701
- 180603845
- SZ151100022
- 180603489
- SZ160801811
- 180603829
- 151100395
- 180101912
- 181102643
- 160800430
- 180603799
Distribution
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