Philips recalls all Medichoice Infant Heel Warmers due to FDA labeling changes needed for 510(k) clearance. Affected units require new regulatory approval before safe use.
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 Medichoice Infant Heel Warmers because the devices have modified labeling that no longer meet FDA clearance requirements. This means the products cannot be legally sold without new regulatory approval.
The devices have been modified with new labeling that does not meet existing FDA clearance standards. This means they cannot be legally distributed or sold without additional regulatory approval from the FDA.
Parents and caregivers who purchased the Medichoice Infant Heel Warmer for babies are affected. The risk is low since the devices are not currently being sold without proper clearance.
All units of the Medichoice Infant Heel Warmer with reference number 989805643721 1079906 are affected. The product was sold by Philips North America.
Look for the reference number 989805643721 1079906 on the device.
The devices have modified labeling that no longer meet FDA clearance requirements, so they cannot be legally sold without new regulatory approval.
No, the product is not currently being sold without proper clearance, so there is no immediate risk.
The official recall notice does not mention a replacement or remedy for this product.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0509-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-0509-2022 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.
