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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

Liberty Medical Solutions, LLC: Multi-Mode Stimulators Recalled for Missing Safety Warnings

Agency Publication Date: December 7, 2023
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Summary

Liberty Medical Solutions, LLC is recalling 473 Multi-Mode Stimulators (Transcutaneous Electrical Nerve Stimulation or TENS units) because the instruction manuals provided with devices distributed between 2018 and 2023 were missing critical safety warnings and contraindications. These manuals did not inform users of important conditions or situations where the device should not be used, which could lead to improper use of the electrical stimulator. Consumers should contact their healthcare provider or the manufacturer to receive updated safety information and instructions.

Risk

Missing safety warnings and contraindications in the user manual can lead patients to use the device in unsafe conditions, potentially resulting in adverse reactions or injuries that the user was not properly warned about.

What You Should Do

  1. Locate your Multi-Mode Stimulator and check the serial number and UDI/DI on the device or its packaging.
  2. Verify if your device is affected by matching it to UDI/DI 00860000178303 or one of the over 400 specific serial numbers, such as 181102627, 180101759, 180302368, or SZ151100022.
  3. Contact your healthcare provider to discuss whether you have been using the device safely and to understand the missing contraindications.
  4. Contact Liberty Medical Solutions, LLC at 3653 Madaca Ln, Tampa, Florida, 33618-2048 to request a corrected instruction manual that includes all appropriate warnings.
  5. For additional questions or to report a problem, contact the FDA directly at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Corrective instructions/warnings update

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
UPC Codes:
00860000178303
Lot Numbers (471):
181102627
180101759
180302368
180603258
180101748
180603502
160700386
170305821
170305701
180603845
SZ151100022
180603489
SZ160801811
180603829
151100395
180101912
181102643
160800430
180603799
160800489
181102635
181102714
180302357
181102642
161202284
160800483
180603914
180101917
161202293
161202285
181102649
160107765
180603065
180603924
SZ160502068
180603841
180603864
160800092
180603059
160800417
SZ160700097
170305806
160800493
161202287
181102646
181102789
180101911
SZ151100005
180603839
SZ151100017
Date Ranges: Distributed from 2018 to 2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93277
Status: Active
Manufacturer: Liberty Medical Solutions, LLC
Sold By: Authorized medical device distributors; Direct distribution
Manufactured In: United States
Units Affected: 473 units
Distributed To: Connecticut, Florida, North Carolina, New Jersey, New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.