# FDA recall Z-0506-2022

> **Philips North America Llc** · Class II · device recall initiated 2021-11-29.

## Product

Infant Heel Warmers w/strap, Reference # 989805603201 1223

## 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.

## Distribution

US Nationwide and Canada.

## Key facts

- **Recall number:** Z-0506-2022
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-29
- **Report date:** 2022-01-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0506-2022

## Citation

> AI Analytics. FDA recall Z-0506-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0506-2022. Source: US FDA. Licensed CC0.

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