Philips North America Llc: Medical Device Recall in 2022 - (Recall #: Z-0508-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T

Product Classification:

Class II

Date Initiated: November 29, 2021

Date Posted: January 26, 2022

Recall Number: Z-0508-2022

Event ID: 89163

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 4,920,600 units

Code Information:

All units are impacted

Distribution Pattern:

US Nationwide and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated