CooperSurgical Infant Heel Gel Warmers — Class II medical device recall Z-1298-2015
Terminated recall by CooperSurgical, Inc., reported 2015-03-25, distributed nationwide. Products without expiration date have the remote potential for minor burn
| Recall number | Z-1298-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2015-01-26 |
| Classified | 2015-03-19 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2016-06-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BH, BM, CA, FR, LV, MX, NZ, QA, SA, SG |
| Quantity | 20,398,889 units |
Product
CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection
Reason for recall
Products without expiration date have the remote potential for minor burn
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-1298-2015. 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.