Infa-Therm Transport Mattress — Class II medical device recall Z-0505-2022
Ongoing recall by Philips North America Llc, reported 2022-01-26, distributed nationwide. After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the exis
| Recall number | Z-0505-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips North America Llc, Cambridge, MA, United States |
| Recall initiated | 2021-11-26 |
| Classified | 2022-01-18 |
| Reported by FDA | 2022-01-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00989805616831 |
Product
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0505-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.