Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 26, 2022
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
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 b…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips North America Llc recalled Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 - a moderate-severity action.
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906 was recalled by Philips North America Llc in January 26, 2022. Reason: After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the exi…. Check the official notice for the remedy. Verify recall #Z-0509-2022 with the FDA Devices before acting.
The recall
Philips North America Llc issued this moderate-severity FDA Devices recall-After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the exi….
- Moderate
- severity level
- 2.9M units
- affected scope
- Class II
- classification
- January 26, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0509-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0509-2022) was formally reported on January 26, 2022, with the manufacturer initiating the action on November 29, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Philips North America Llc is listed as the recalling firm, operating out of Cambridge, MA. Federal records list the affected scope as 2,925,800 units, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: 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)… Distribution data in the federal record shows the product reached: US Nationwide and Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,925,800 units
Related Recalls
6
3 from same agency
Product description
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0509-2022 |
| Date reported | January 26, 2022 |
| Date initiated | November 29, 2021 |
| Recalling firm | Philips North America Llc |
| Firm location | Cambridge, MA |
| Affected scope | 2,925,800 units |
| Distribution | US Nationwide and Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0509-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906. Recalled by Philips North America Llc. Units affected: 2,925,800 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 26, 2022. Severity: Moderate. Recall number: Z-0509-2022.
Where was the recalled product distributed? ▼
Distribution: US Nationwide and Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0509-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 26, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.