FDA Device recall Z-1361-2024
Thermalon Sinus Compress, Item Number 24332
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of Thermalon Sinus Compress, Item Number 24332 by Bruder Healthcare, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1361-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-21 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Bruder Healthcare |
| Distribution | US |
Product
Thermalon Sinus Compress, Item Number 24332
Reason
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.
Identifiers
| upc | 041533243328 |
|---|---|
| code_info | UPC 041533243328, Lot Numbers: M053160, M053570 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1361-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.