Philips recalls all Cardinal Infant Heel Warmers with reference # 98980: FDA labeling changes needed for new 510(k) clearance. No action required for consumers.
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.
Philips is recalling all Cardinal Infant Heel Warmers with reference number 989805617251 11470-010T due to FDA labeling requirements. The recall is related to regulatory compliance, not a safety hazard for users.
The devices require updated FDA labeling for new 510(k) clearance. Without this, they cannot be legally sold. This is a regulatory issue, not a safety hazard for users.
All owners of the Cardinal Infant Heel Warmer with reference # 989805617251 11470-010T are affected. Parents and caregivers using the product are at risk of regulatory non-compliance.
Check for the reference number 989805617251 11470-010T on the product packaging. All units of this model are impacted by the recall.
Look for the reference number 989805617251 11470-010T on the product packaging.
No action is required for consumers. This recall is for regulatory compliance, not a safety hazard.
Philips made changes to the labeling that require new FDA 510(k) clearance. The devices cannot be legally sold without this update.
No. This recall is a regulatory issue, not a safety hazard for users.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0508-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-0508-2022 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
