Cocoon Convective Warming System — Class II medical device recall Z-0986-2020
Terminated recall by Care Essentials Pty., Ltd., reported 2020-02-12, distributed nationwide. Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connec
| Recall number | Z-0986-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Care Essentials Pty., Ltd., North Geelong, N/A, Australia |
| Recall initiated | 2020-01-07 |
| Classified | 2020-02-04 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2023-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 689 |
| Serial numbers | CWS4-10001-14, CWS4-10002-14, CWS4-10003-14, CWS4-10004-14, CWS4-10005-14, CWS4-10006-14, CWS4-10007-14, CWS4-10008-14, CWS4-10009-14, CWS4-10010-14, CWS4-10011-14, CWS4-10012-14, CWS4-10013-14, CWS4-10014-14, CWS4-10015-14, CWS4-10016-14, CWS4-10017-14, CWS4-10018-14, CWS4-10020-14, CWS4-10021-14, CWS4-10022-14, CWS4-10023-14, CWS4-10024-14, CWS4-10025-14, CWS4-10026-14 and 475 more |
Product
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
Reason for recall
Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.
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-0986-2020. 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.