Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Infa-Therm Transport Mattress Recalled by Philips North America Llc Due to After the device was cleared by the FDA,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips North America Llc directly.
Affected Products
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Quantity: 141,744 units (Updated to 141,750 units as of 2/15/22)
Why Was This Recalled?
After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips North America Llc
Philips North America Llc has 301 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report