The Recall Desk
HighFDA (Devices)·Z-1359-2024·Announced 2024-04-03

Thermalon Eye Compress Recalled Due to Potential Mold and Mildew Growth

Bruder Healthcare Company is recalling Thermalon Eye Compress Item 2434 from certain lots due to potential mold and mildew growth from excessive moisture exposure. Affected products were distributed in the US and Canada.

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: This is an FDA Class II recall for potential microbial contamination (mold and mildew) with no reported illnesses or injuries. The recall meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as mold and mildew exposure to the eye area poses a potential health risk.

Plain-English summary

Bruder Healthcare Company, LLC is recalling Thermalon Eye Compress, Item Number 2434, from certain lots due to potential mold and mildew growth. Approximately 2400 units with lot code M056410 are affected.

The compressed packs may have been exposed to excessive moisture, creating conditions for potential mold and mildew growth.

The affected products were distributed nationwide throughout the United States and in Canada.

Consumers with the affected product should discontinue use and contact Bruder Healthcare Company with any questions or concerns.

The recalled product

Product
Thermalon Eye Compress, Item Number 2434
Manufacturer
Bruder Healthcare Company, LLC
Hazard
  • mold
  • mildew

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 (2)

  • UPC 041533243427
  • Lot Codes: M056410

Distribution

Distributed nationwide across the United States.