UnratedMedical device recall · FDA · Published November 26, 2021
Philips Infa-Therm Transport Mattress Recall: FDA Labeling Changes Required
Philips recalls all Infa-Therm Transport Mattresses with reference number 989805616831 1015 due to FDA labeling changes needed for 510(k) clearance. No action is required as the devices are not yet legally sold.
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.
Take action
Contact the company
📍Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289
“Philips Infa-Therm Transport Mattress Recall: FDA Labeling Changes Required.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/61498-philips-infa-therm-transport-mattress-recall-fda-labeling-changes-required. Based on FDA recall #Z-0505-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0505-2022%22&limit=1).
Philips North America Llc recalled the Infa-Therm Transport Mattress, Reference Number 989805616831 1015, because modified labeling lacks required FDA clearance, according to the FDA. The Food and Drug Administration announced the voluntary Class II recall on November 26, 2021.
How to tell if you have it
Brand: Philips
Product: Infa-Therm Transport Mattress
Reference Number: 989805616831 1015
The hazard
The device was cleared by the FDA, but Philips made changes to the labeling that do not fall within the existing clearance. These devices with the modified labeling cannot be distributed or sold without new 510(k) clearance.
Context
GovInfoNow's records show Philips North America Llc has 129 other recalls on record since July 12, 2017. Recent recalls include a SmartPath to dStream software issue (August 21, 2026) and a Spectral CT 7500 Scanner radiation risk (August 18, 2026). Other recent recalls of similar products include Silent Nite Sleep Appliance Recall: FDA Clearance Missing (April 27, 2026), Medline Convenience Kits with Unapproved Syringes Recalled: FDA Design Changes (February 27, 2026), and Covidien Mon-a-Therm Temperature Probe Recall: Lack of FDA Clearance (April 23, 2026).
How to tell if you have this one
Check for the reference number 989805616831 1015 on the Infa-Therm Transport Mattress. All units are impacted by this recall.
Brand
Philips
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the reference number 989805616831 1015 on the mattress to confirm it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide and Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0505-2022 (November 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0505-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.