Philips recalls all Infant Heel Warmers with reference # 98980: FDA labeling changes needed for new clearance. No action required for safety.
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 Infant Heel Warmers with reference number 989805603201 1223 due to FDA labeling requirements. The recall does not pose a safety risk but requires updated labeling for legal compliance.
The devices were cleared by the FDA but require updated labeling for new 510(k) clearance. Without these changes, they cannot be legally sold or distributed. This is a regulatory issue, not a safety hazard.
All owners of Philips Infant Heel Warmers with reference number 989805603201 1223 are affected. Parents using these warmers for infants are most at risk of non-compliance with FDA labeling.
Check for the reference number 989805603201 1223 on the product. All units of this specific model are impacted by the recall.
Look for the reference number 989805603201 1223 on the Infant Heel Warmer.
No, the recall is for regulatory compliance only. The devices are safe to use but require updated labeling for legal distribution.
No action is required for safety. The recall does not pose a safety risk but needs updated labeling for FDA compliance.
No specific action is needed. The recall is for regulatory purposes only and does not affect safety.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0506-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-0506-2022 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.
