Philips recalls all Heel Snuggler devices with reference numbers 989805603411 and 99047 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.
Philips is recalling all Heel Snugg: devices with reference numbers 989805603411 and 99047 because they were sold without proper FDA labeling. This means the products are not legally compliant and should not be used until the labeling meets new FDA requirements.
The devices were sold without the necessary FDA labeling changes required for 510(k) clearance. This means they do not meet current regulatory standards and could be sold illegally without proper safety documentation.
All owners of Heel Snuggler devices with reference numbers 989805603411 and 99047 are affected. The risk is highest for those who have purchased these devices from retailers that sold them without updated FDA labeling.
Check for reference numbers 989805603411 or 99047 on the Heel Snuggler device. All units are impacted, so any device with these reference numbers is affected.
Look for reference numbers 989805603411 or 99047 on the Heel Snuggler device.
No action is required as the devices are not yet legally sold. The recall is for products that were sold without proper FDA labeling, but they are not currently in use.
Philips made changes to the labeling that do not fall within existing FDA clearance requirements. These devices cannot be legally sold without new 510(k) clearance.
Check for reference numbers 989805603411 or 99047 on the device. All units with these reference numbers are impacted.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0507-2022 — Philips Philips Hello, I own a Philips that is covered by recall Z-0507-2022 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.
