Thermalon Heating Pad, Item Number 24002
FDA Device Recall #Z-1364-2024 — Class II — February 21, 2024
Recall Summary
| Recall Number | Z-1364-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 21, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bruder Healthcare Company, LLC |
| Location | Alpharetta, GA |
| Product Type | Devices |
| Quantity | 1656 units |
Product Description
Thermalon Heating Pad, Item Number 24002
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Lot / Code Information
UPC 041533240020, Lot Numbers: M055930
Other Recalls from Bruder Healthcare Company, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1365-2024 | Class II | Thermalon Stye Compress, Item Number 24352 | Feb 21, 2024 |
| Z-1360-2024 | Class II | Thermalon Sinus Compress (French), Item Number ... | Feb 21, 2024 |
| Z-1362-2024 | Class II | Thermalon Back Wrap, Item Number 24312 | Feb 21, 2024 |
| Z-1361-2024 | Class II | Thermalon Sinus Compress, Item Number 24332 | Feb 21, 2024 |
| Z-1363-2024 | Class II | Thermalon Neck Wrap, Item Number 24322 | Feb 21, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.