Thermalon Sinus Compress — Class II medical device recall Z-1361-2024
Ongoing recall by Bruder Healthcare Company, LLC, reported 2024-04-03, distributed nationwide. Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, r
| Recall number | Z-1361-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bruder Healthcare Company, LLC, Alpharetta, GA, United States |
| Recall initiated | 2024-02-21 |
| Classified | 2024-03-22 |
| Reported by FDA | 2024-04-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,416 units |
| Reason classes | microbial contamination |
| Pathogens | mold |
| UPC / GTIN / UDI-DI | 00041533243328 |
| Lot numbers | M053160, M053570 |
| Model numbers | 24332 |
Product
Thermalon Sinus Compress, Item Number 24332
Reason for recall
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1361-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.