FDA-Device2022-01-26Class II
Heel Snuggler, Reference # 989805603411 99047
Hazard
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.
Sold states
US Nationwide and Canada.
Affected count
2,509,100 units (Updated to 2,515,200 as of 2/15/22)
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Heel Snuggler, Reference # 989805603411 99047
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0507-2022More Philips North America Llc recalls
- FDA-Device2026-07-01Philips Avalon FM20 Fetal Monitor recalled for speaker connector assembly defect
- FDA-Device2026-07-01Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
- FDA-Device2026-07-01Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.
- FDA-Device2026-06-17Philips DigitalDiagnost C90 Flex/Value/Chest/ER recalled for missing seismic stabilization kit
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