Z-1361-2024Class II

Thermalon Sinus Compress, Item Number 24332

Name: Z-1361-2024 Thermalon Sinus Compress, Item Number 24332
Creator: Bruder Healthcare Company, LLC
Published: 2024-02-21
License: https://open.fda.gov/license/

Bruder Healthcare Company / initiated 2024-02-21 / Open, Classified

FDA source

Bruder Healthcare Company, LLC began a recall of Thermalon Sinus Compress, Item Number 24332 on 2024-02-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1361-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-21
Posted: 2024-03-22
Recalling firm: Bruder Healthcare Company
Product: Thermalon Sinus Compress, Item Number 24332
Product code: IMA Pack, Heat, Moist
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.
FDA root cause: Under Investigation by firm
Action: Bruder Healthcare Company sent an email to its consignees on XXX to notify them of the recall. The email explained the issue and requested the consignees cease distribution of affected stock and contact Bruder Healthcare Company for instructions on returning the product. Distributors were directed to forward the recall communication to their customers.
Quantity in commerce: 1416 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: UPC 041533243328, Lot Numbers: M053160, M053570

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1361-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1359-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22
Z-1360-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22
Z-1361-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22
Z-1362-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22
Z-1363-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22
Z-1364-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22
Z-1365-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22
Z-1366-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22
Z-1367-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-22

Product code IMA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)