Covidien Argyle Infant Heel Warmers — Class II medical device recall Z-2444-2015
Terminated recall by Covidien LLC, reported 2015-09-02, distributed nationwide. Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcar
| Recall number | Z-2444-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2015-07-31 |
| Classified | 2015-08-21 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2017-05-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP, MX, PA |
| Reason classes | device malfunction |
| Lot numbers | 309907X, 310604X, 310704X, 312110X, 312329X, 313034X, 313615X, 314212X, 314308X, 317921X, 318904X, 320714X, 320715X, 321312X, 321423X, 321712X, 321812X, 321826X, 321903X, 322120X |
| Model numbers | MH00002T |
Product
Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
Reason for recall
Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2444-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.