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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

Bruder Healthcare Company, LLC: Thermalon and MediBeads Compresses Recalled for Potential Mold Growth

Agency Publication Date: March 22, 2024
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Summary

Bruder Healthcare Company, LLC is recalling 9,335 units of various Thermalon and MediBeads moist heat compresses, including eye, sinus, back, and neck wraps. These products may have been exposed to excessive moisture during production or storage, which can lead to the growth of mold and mildew on the compresses. Affected items include the Thermalon Eye Compress, Sinus Compress, Back Wrap, Neck Wrap, Heating Pad, and Stye Compress, as well as MediBeads Neck Wraps and King Pads.

Risk

The presence of mold and mildew on medical compresses that come into direct contact with the skin, eyes, or sinuses can cause infections or allergic reactions, particularly in individuals with compromised immune systems or mold sensitivities.

What You Should Do

  1. Check your product for the following Item Numbers and Lot Numbers: Thermalon Eye Compress (Item 2434, Lot M056410), Sinus Compress (Item 24332F/24332, Lots M053600, M053340, M053160, M053570), Back Wrap (Item 24312, Lots M053210, M053580, M055910), Neck Wrap (Item 24322, Lots M053560, M053140), Heating Pad (Item 24002, Lot M055930), Stye Compress (Item 24352, Lot M058520), MediBeads Neck Wrap (Item 34320, Lot M053300), and MediBeads King Pad (Items 34120, 34120PM, 34125R, Lots M053590, M053280).
  2. Verify the UPC codes against your packaging: Thermalon Eye (041533243427), Sinus (041533243328), Back (041533243120), Neck (041533243229), Heating Pad (041533240020), Stye (041533243526), MediBeads Neck (041533343202), and MediBeads King Pad (041533341208).
  3. Stop using any affected compress immediately if the lot number matches those listed above.
  4. Contact Bruder Healthcare Company, LLC or your healthcare provider for further instructions regarding a replacement or potential refund for the affected medical device.
  5. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: Thermalon Eye Compress, Item Number 2434
Model / REF:
2434
UPC Codes:
041533243427
Lot Numbers:
M056410
Product: Thermalon Sinus Compress (French), Item Number 24332F
Model / REF:
24332F
UPC Codes:
041533243328
Lot Numbers:
M053600
M053340
Product: Thermalon Sinus Compress, Item Number 24332
Model / REF:
24332
UPC Codes:
041533243328
Lot Numbers:
M053160
M053570
Product: Thermalon Back Wrap, Item Number 24312
Model / REF:
24312
UPC Codes:
041533243120
Lot Numbers:
M053210
M053580
M055910
Product: Thermalon Neck Wrap, Item Number 24322
Model / REF:
24322
UPC Codes:
041533243229
Lot Numbers:
M053560
M053140
Product: Thermalon Heating Pad, Item Number 24002
Model / REF:
24002
UPC Codes:
041533240020
Lot Numbers:
M055930
Product: Thermalon Stye Compress, Item Number 24352
Model / REF:
24352
UPC Codes:
041533243526
Lot Numbers:
M058520
Product: MediBeads Neck Wrap, Item Number 34320
Model / REF:
34320
UPC Codes:
041533343202
Lot Numbers:
M053300
Product: MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R
Model / REF:
34120
34120PM
34125R
UPC Codes:
041533341208
Lot Numbers:
M053590
M053280

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94120
Status: Active
Manufacturer: Bruder Healthcare Company, LLC
Sold By: retailers nationwide
Manufactured In: United States
Units Affected: 9 products (2400 units; 2160 units; 1416 units; 193 units; 471 units; 1656 units; 24 units; 430 units; 585 units)
Distributed To: Nationwide

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

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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.