FDA (Devices) recall action 94120
The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Bruder Healthcare recalls Thermalon Heating Pad model 24002 due to potential mold and mildew growth from moisture exposure. Affected units were distributed nationwide in the US and to Canada.
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.
Bruder Healthcare Company is recalling 1,416 units of Thermalon Sinus Compress (Item Number 24332) due to potential mold and mildew growth from excessive moisture exposure. Affected lot numbers are M053160 and M053570.
Bruder Healthcare Company is recalling certain lots of Thermalon Sinus Compress due to potential mold and mildew growth from moisture exposure. The product was distributed in the US and Canada.
Certain lots of Thermalon Back Wrap may have been exposed to excessive moisture, potentially resulting in mold and mildew growth. The product is distributed nationwide in the US and Canada.
Bruder Healthcare Company is recalling Thermalon Stye Compress (Item Number 24352) in certain lots due to potential mold and mildew growth from excessive moisture exposure. No illnesses have been reported.
Bruder Healthcare Company is recalling 430 units of MediBeads Neck Wrap (Item 34320) because the product may have been exposed to excessive moisture, creating potential for mold and mildew growth. Lot Number M053300, distributed in the US and Canada.
Bruder Healthcare Company is recalling Thermalon Neck Wrap (Item Number 24322) from certain lots due to potential mold and mildew growth from excessive moisture exposure. Consumers should discontinue use and contact the manufacturer.
Bruder Healthcare is recalling MediBeads King Pad moist heat compresses (item numbers 34120, 34120PM, 34125R) from certain lots due to potential mold and mildew growth from excessive moisture exposure.