Class II — CooperSurgical, Inc.
| Recalling firm | COOPERSURGICAL, INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Products without expiration date have the remote potential for minor burn |
| 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 |
| Quantity | 20398889 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM. |
| Initiated | 2015-01-26 |
| Classified | 2015-03-19 |
| Terminated | 2016-06-14 |
| Recall number | Z-1298-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CooperSurgical, Inc. (Z-1298-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70286/
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