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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84541

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 07, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Care Essentials Pty., Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Cocoon Convective Warming System, Product Code: CWS4000 (110V).

Z-0986-2020
Recall number
Z-0986-2020
Initiated
January 07, 2020
Classification
Class II
Status
Terminated
Quantity
689

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code: CWS4000 (110V) 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, CWS4-10027-14, CWS4-10028-14, CWS4-10029-14, CWS4-10030-14, CWS4-10031-14, CWS4-10032-14, CWS4-10033-14, CWS4-10035-14, CWS4-10036-14, CWS4-10037-14, CWS4-10038-14, CWS4-10039-14, CWS4-10040-14, CWS4-10041-14, CWS4-10042-14, CWS4-10043-14, CWS4-10044-14, CWS4-10045-14, CWS4-10046-14, CWS4-10047-14, CWS4-10049-14, CWS4-10050-14, CWS4-10051-14, CWS4-10052-14, CWS4-10053-14, CWS4-10054-14, CWS4-10055-14, CWS4-10056-14, CWS4-10057-14, CWS4-10058-14, CWS4-10059-14, CWS4-10060-14, CWS4-10061-14, CWS4-10062-14, CWS4-10063-14, CWS4-10064-14, CWS4-10065-14, CWS4-10066-14, CWS4-10067-14, CWS4-10068-14, CWS4-10069-14, CWS4-10070-14, CWS4-10071-14, CWS4-10072-14, CWS4-10073-14, CWS4-10074-14, CWS4-10075-14, CWS4-10076-14, CWS4-10077-14, CWS4-10078-14, CWS4-10079-14, CWS4-10080-14, CWS4-10081-14, CWS4-10082-14, CWS4-10083-14, CWS4-10084-14, CWS4-10085-14, CWS4-10086-14, CWS4-10087-14, CWS4-10088-14, CWS4-10089-14, CWS4-10090-14, CWS4-10091-14, CWS4-10092-14, CWS4-10093-14, CWS4-10094-14, CWS4-10095-14, CWS4-10096-14, CWS4-10201-15, CWS4-10206-15, CWS4-10207-15, CWS4-10208-15, CWS4-10209-15, CWS4-10210-15, CWS4-10211-15, CWS4-10212-15, CWS4-10213-15, CWS4-10214-15, CWS4-10215-15, CWS4-10216-15, CWS4-10217-15, CWS4-10218-15, CWS4-10219-15, CWS4-10220-15, CWS4-10221-15, CWS4-10222-15, CWS4-10223-15, CWS4-10245-15, CWS4-10246-15, CWS4-10247-15, CWS4-10248-15, CWS4-10249-15, CWS4-10250-15, CWS4-10251-15, CWS4-10252-15, CWS4-10253-15, CWS4-10254-15, CWS4-10255-15, CWS4-10256-15, CWS4-10257-15, CWS4-10258-15, CWS4-10259-15, CWS4-10260-15, CWS4-10261-15, CWS4-10262-15, CWS4-10263-15, CWS4-10264-15, CWS4-10265-15, CWS4-10266-15, CWS4-10267-15, CWS4-10268-15, CWS4-10269-15, CWS4-10270-15, CWS4-10271-15, CWS4-10272-15, CWS4-10273-15, CWS4-10274-15, CWS4-10275-15, CWS4-10276-15, CWS4-10277-15, CWS4-10278-15, CWS4-10280-15, CWS4-10281-15, CWS4-10282-15, CWS4-10283-15, CWS4-10284-15, CWS4-10285-15, CWS4-10286-15, CWS4-10287-15, CWS4-10288-15, CWS4-10289-15, CWS4-10290-15, CWS4-10291-15, CWS4-10292-15, CWS4-10293-15, CWS4-10294-15, CWS4-10295-15, CWS4-10296-15, CWS4-10297-15, CWS4-10298-15, CWS4-10299-15, CWS4-10300-15, CWS4-10301-15, CWS4-10302-15, CWS4-10304-15, CWS4-10305-15, CWS4-10306-15, CWS4-10307-15, CWS4-10308-15, CWS4-10309-15, CWS4-10310-15, CWS4-10311-15, CWS4-10312-15, CWS4-10313-15, CWS4-10314-15, CWS4-10315-15, CWS4-10316-15, CWS4-10317-15, CWS4-10318-15, CWS4-10319-15, CWS4-10320-15, CWS4-10321-15, CWS4-10322-15, CWS4-10323-15, CWS4-10325-15, CWS4-10326-15, CWS4-10327-15, CWS4-10328-15, CWS4-10329-15, CWS4-10330-15, CWS4-10331-15, CWS4-10332-15, CWS4-10333-15, CWS4-10334-15, CWS4-10335-15, CWS4-10336-15, CWS4-10337-15, CWS4-10338-15, CWS4-10339-15, CWS4-10340-15, CWS4-10341-15, CWS4-10342-15, CWS4-10343-15, CWS4-10344-15, CWS4-10345-15, CWS4-10346-15, CWS4-10347-15, CWS4-10348-15, CWS4-10349-15, CWS4-10350-15, CWS4-10351-15, CWS4-10352-15, CWS4-10353-15, CWS4-10354-15, CWS4-10355-15, CWS4-10356-15, CWS4-10357-15, CWS4-10358-15, CWS4-10359-15, CWS4-10360-15, CWS4-10361-15, CWS4-10362-15, CWS4-10363-15, CWS4-10364-15, CWS4-10365-15, CWS4-10366-15, CWS4-10367-15, CWS4-10368-15, CWS4-10369-15, CWS4-10370-15, CWS4-10371-15, CWS4-10372-15, CWS4-10373-15, CWS4-10374-15, CWS4-10375-15, CWS4-10376-15, CWS4-10377-15, CWS4-10378-15, CWS4-10379-15, CWS4-10382-15, CWS4-10383-15, CWS4-10384-15, CWS4-10385-15, CWS4-10386-15, CWS4-10387-15, CWS4-10388-15, CWS4-10389-15, CWS4-10390-15, CWS4-10391-15, CWS4-10392-15, CWS4-10393-15, CWS4-10394-15, CWS4-10395-15, CWS4-10396-15, CWS4-10397-15, CWS4-10398-15, CWS4-10401-15, CWS4-10421-15, CWS4-10434-15, CWS4-10435-15, CWS4-10436-15, CWS4-10437-15, CWS4-10438-15, CWS4-10439-15, CWS4-10440-15, CWS4-10441-15, CWS4-10442-15, CWS4-10443-15, CWS4-10444-15, CWS4-10445-15, CWS4-10446-15, CWS4-10447-15, CWS4-10448-15, CWS4-10449-15, CWS4-10450-15, CWS4-10451-15, CWS4-10457-15, CWS4-10458-15, CWS4-10459-15, CWS4-10460-15, CWS4-10461-15, CWS4-10462-15, CWS4-10463-15, CWS4-10464-15, CWS4-10465-15, CWS4-10466-15, CWS4-10467-15, CWS4-10468-15, CWS4-10469-15, CWS4-10470-15, CWS4-10471-15, CWS4-10472-15, CWS4-10473-15, CWS4-10474-15, CWS4-10475-15, CWS4-10476-15, CWS4-10477-15, CWS4-10478-15, CWS4-10479-15, CWS4-10480-15, CWS4-10481-15, CWS4-10482-15, CWS4-10483-15, CWS4-10484-15, CWS4-10485-15, CWS4-10486-15, CWS4-10487-15, CWS4-10488-15, CWS4-10489-15, CWS4-10490-15, CWS4-10491-15, CWS4-10492-15, CWS4-10493-15, CWS4-10494-15, CWS4-10495-15, CWS4-10496-15, CWS4-10497-15, CWS4-10498-15, CWS4-10499-15, CWS4-10500-15, CWS4-10501-15, CWS4-10502-15, CWS4-10503-15, CWS4-10504-15, CWS4-10505-15, CWS4-10506-15, CWS4-10507-15, CWS4-10508-15, CWS4-10509-15, CWS4-10510-15, CWS4-10511-15, CWS4-10512-15, CWS4-10513-15, CWS4-10514-15, CWS4-10515-15, CWS4-10516-15, CWS4-10517-15, CWS4-10518-15, CWS4-10519-15, CWS4-10520-15, CWS4-10521-15, CWS4-10522-15, CWS4-10523-15, CWS4-10524-15, CWS4-10525-15, CWS4-10526-15, CWS4-10527-15, CWS4-10528-15, CWS4-10529-15, CWS4-10530-15, CWS4-10531-15, CWS4-10532-15, CWS4-10533-15, CWS4-10534-15, CWS4-10535-15, CWS4-10536-15, CWS4-10537-15, CWS4-10538-15, CWS4-10539-15, CWS4-10540-15, CWS4-10541-15, CWS4-10542-15, CWS4-10543-15, CWS4-10544-15, CWS4-10545-15, CWS4-10546-15, CWS4-10547-15, CWS4-10549-15, CWS4-10550-15, CWS4-10551-15, CWS4-10552-15, CWS4-10553-15, CWS4-10554-15, CWS4-10555-15, CWS4-10556-15, CWS4-10557-15, CWS4-10558-15, CWS4-10559-15, CWS4-10560-15, WS4-10561-15, CWS4-10562-15, CWS4-10563-15, CWS4-10564-15, CWS4-10565-15, CWS4-10566-15, CWS4-10567-15, CWS4-10568-15, CWS4-10569-15, CWS4-10570-15, CWS4-10571-15, CWS4-10572-15, CWS4-10573-15, CWS4-10574-15, CWS4-10575-15, CWS4-10576-15, CWS4-10577-15, CWS4-10578-15, CWS4-10579-15, CWS4-10580-15, CWS4-10581-15, CWS4-10582-15, CWS4-10583-15, CWS4-10584-15, CWS4-10585-15, CWS4-10586-15, CWS4-10587-15, CWS4-10588-15, CWS4-10589-15, CWS4-10590-15, CWS4-10591-15, CWS4-10592-15, CWS4-10593-15, CWS4-10594-15, CWS4-10595-15, CWS4-10596-15, CWS4-10597-15, CWS4-10598-15, CWS4-10599-15, CWS4-10600-15, CWS4-10601-15, CWS4-10602-15, CWS4-10603-15, CWS4-10604-15, CWS4-10605-15, CWS4-10606-15, CWS4-10607-15, CWS4-10608-15, CWS4-10609-15, CWS4-10610-15, CWS4-10611-15, CWS4-10612-15, CWS4-10613-15, CWS4-10614-15, CWS4-10615-15, CWS4-10616-15, CWS4-10617-15, CWS4-10619-15, CWS4-10620-15, CWS4-10621-15, CWS4-10622-15, CWS4-10623-15, CWS4-10624-15, CWS4-10625-15, CWS4-10626-15, CWS4-10627-15, CWS4-10628-15, CWS4-10629-15, CWS4-10630-15, CWS4-10631-15, CWS4-10632-15, CWS4-10633-15, CWS4-10634-15, CWS4-10635-15, CWS4-10636-15, CWS4-10637-15, CWS4-10638-15, CWS4-10639-15, CWS4-10640-15, CWS4-10641-15, CWS4-10642-15, CWS4-10643-15, CWS4-10644-15, CWS4-10645-15, CWS4-10646-15, CWS4-10647-15, CWS4-10648-15, CWS4-10649-15, CWS4-10650-15, CWS4-10651-15, CWS4-10652-15, CWS4-10653-15, CWS4-10654-15, CWS4-10655-15, CWS4-10656-15, CWS4-10657-15, CWS4-10658-15, CWS4-10659-15, CWS4-10660-15, CWS4-10661-15, CWS4-10662-15, CWS4-10663-15, CWS4-10664-15, CWS4-10665-15, CWS4-10666-15, CWS4-10667-15, CWS4-10668-15, CWS4-10669-15, CWS4-10670-15, CWS4-10671-15, CWS4-10672-15, CWS4-10673-15, CWS4-10674-15, CWS4-10675-15, CWS4-10676-15, CWS4-10677-15m CWS4-10678-15, CWS4-10679-15, CWS4-10680-15m CWS4-10681-15, CWS4-10682-15, CWS4-10683-15, CWS4-10684-15, CWS4-10685-15, CWS4-10686-15, CWS4-10687-15, CWS4-10688-15, CWS4-10689-15, CWS4-10690-15, CWS4-10691-15, CWS4-10692-15, CWS4-10694-15, CWS4-10695-15, CWS4-10696-15, CWS4-10697-15, CWS4-10698-15, CWS4-10699-15, CWS4-10700-15, CWS4-10701-15, CWS4-10702-15, CWS4-10703-15, CWS4-10704-15, CWS4-10705-15, CWS4-10706-15, CWS4-10727-15, CWS4-10728-15, CWS4-10729-15, CWS4-10730-15, CWS4-10731-15, CWS4-10732-15, CWS4-10733-15, CWS4-10734-15, CWS4-10736-15, CWS4-10737-15, CWS4-10738-15, CWS4-10739-15, CWS4-10740-15, CWS4-10741-15, CWS4-10742-15, CWS4-10793-15, CWS4-10794-15, CWS4-10795-15, CWS4-10796-15, CWS4-10797-15, CWS4-10798-15, CWS4-10799-15, CWS4-10800-15, CWS4-10801-15, CWS4-10802-15, CWS4-10803-15, CWS4-10804-15, CWS4-10805-15, CWS4-10806-15, CWS4-10807-15, CWS4-10808-15, CWS4-10809-15, CWS4-10810-15, CWS4-10811-15, CWS4-10812-15, CWS4-10813-15, CWS4-10814-15, CWS4-10815-15, CWS4-10816-15, CWS4-10817-15, CWS4-10818-15, CWS4-10819-15, CWS4-10820-15, CWS4-10821-15, CWS4-10822-15, CWS4-10823-15, CWS4-10824-15, CWS4-10825-15, CWS4-10826-15, CWS4-10827-15, CWS4-10828-15, CWS4-10829-15, CWS4-10830-15, CWS4-10831-15, CWS4-10832-15, CWS4-10833-15, CWS4-10834-15, CWS4-10835-15, CWS4-10836-15, CWS4-10837-15, CWS4-10838-15, CWS4-10839-15, CWS4-10840-15, CWS4-10841-15, CWS4-10842-15, CWS4-10843-15, CWS4-10844-15, CWS4-10845-15, CWS4-10846-15, CWS4-10847-15, CWS4-10848-15, CWS4-10849-15, CWS4-10850-15, CWS4-10851-15, CWS4-10852-15, CWS4-10853-15, CWS4-10854-15, CWS4-10855-15, CWS4-10856-15, CWS4-10857-15, CWS4-10858-15, CWS4-10859-15, CWS4-10860-15, CWS4-10861-15, CWS4-10862-15, CWS4-10863-15, CWS4-10864-15, CWS4-10865-15, CWS4-10866-15, CWS4-10867-15, CWS4-10868-15, CWS4-5023-13, CWS4-5026-13, CWS4-5027-13, CWS4-5028-13, CWS4-5029-13, CWS4-5030-13, CWS4-5031-13, CWS4-5032-13, CWS4-5033-13, CWS4-5035-13, CWS4-5036-13, CWS4-5037-13, CWS4-5038-13, CWS4-5039-13, CWS4-5040-13, CWS4-5041-13, CWS4-5042-13, CWS4-5043-13, CWS4-5044-13, CWS4-5045-13, CWS4-5046-13, CWS4-5047-13, CWS4-5048-13, CWS4-5050-13, CWS4-5051-13, CWS4-5052-13, CWS4-5053-13, CWS4-5054-13, CWS4-5055-13, CWS4-5056-13, CWS4-5057-14, CWS4-5058-14, CWS4-5059-14, CWS4-5060-14, CWS4-5063-14, CWS4-5064-14, CWS4-5065-14, CWS4-5066-14, CWS4-5067-14, CWS4-5068-14, CWS4-5069-14, CWS4-5070-14, CWS4-5071-14, CWS4-5072-14, CWS4-5073-14, CWS4-5074-14, CWS4-5075-14, CWS4-5076-14, CWS4-5077-14, CWS4-5078-14, CWS4-5079-14, CWS4-5080-14, CWS4-5081-14, CWS4-5082-14, CWS4-5084-14, CWS4-5085-14, CWS4-5086-14, CWS4-5088-14, CWS4-5089-14, CWS4-5090-14, CWS4-5091-14, CWS4-5092-14, CWS4-5093-14, CWS4-5094-14, CWS4-5095-14, CWS4-5096-14, CWS4-5097-14, CWS4-5098-14, CWS4-5100-14, CWS4-5101-14

Distribution pattern

US Nationwide in the states of AZ CA FL GA KS LA MA MD MI MN NC NM NY OH PA QC SC TX VA WV and the Foreign distribution to Canada.

device · product 2 of 2

Cocoon Convective Warming System, Product Code: CWS5000 (110V).

Z-0987-2020
Recall number
Z-0987-2020
Initiated
January 07, 2020
Classification
Class II
Status
Terminated
Quantity
251

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Product Code: CWS5000 (110V) Serial Numbers: CWS5-400001-18, CWS5-400011-18, S00001, S00003, S00004, S00006, S00007, S00008, S00009, S00010, S00011, S00012, S00013, S00014, S00015, S00016, S00017, S00018, S00019, S00020, S00021, S00022, S00023, S00024, S00025, S00026, S00027, S00028, S00029, S00030, S00031, S00032, S00033, S00034, S00035, S00036, S00037, S00038, S00039, S00040, S00041, S00042, S00043, S00044, S00045, S00046, S00047, S00048, S00049, S00050, S00051, S00052, S00053, S00054, S00055, S00056, S00057, S00058, S00059, S00060, S00061, S00062, S00063, S00064, S00065, S00066, S00067, S00068, S00069, S00070, S00071, S00072, S00073, S00074, S00075, S00076, S00077, S00078, S00079, S00080, S00081, S00082, S00083, S00084, S00085, S00086, S00087, S00088, S00089, S00090, S00091, S00092, S00093, S00094, S00095, S00096, S00098, S00099, S00100, S00101, S00102, S00103, S00104, S00105, S00106, S00107, S00108, S00109, S00110, S00111, S00112, S00113, S00114, S00115. S00116, S00117, S00118, S00119, S00120, S00121, S00122, S00123, S00124, S00125, S00126, S00127, S00128, S00129, S00130, S00131, S00132, S00133, S00134, S00135, S00136, S00137, S00138, S00139, S00140, S00141, S00142, S00143, S00144, S00145, S00146, S00147, S00148, S00149, S00150, S00151, S00152, S00153, S00154, S00155, S00156, S00157, S00158, S00159, S00160, S00161, S00162, S00163, S00164, S00165, S00166, S00167, S00168, S00169, S00170, S00171, S00172, S00173, S00174, S00175, S00176, S00177, S00178, S00179, S00180, S00181, S00182, S00183, S00184, S00185, S00186, S00187, S00188, S00189, S00190, S00191, S00192, S00193, S00194, S00195, S00196, S00197, S00198, S00199, S00200, S00201, S00202, S00203, S00204, S00205, S00206, S00207, S00208, S00209, S00210, S00211, S00212, S00213, S00214, S00215, S00216, S00217, S00218, S00219, S00220, S00221, S00222, S00223, S00224, S00225, S00226, S00227, S00228, S00229, S00230, S00231, S00232, S00233, S00234, S00235, S00236, S00237, S00238, S00239, S00240, S00241, S00242, S00243, S00244, S00245, S00246, S00247, S00248, S00249, S00250, S00251, S00252

Distribution pattern

US Nationwide in the states of AZ CA FL GA KS LA MA MD MI MN NC NM NY OH PA QC SC TX VA WV and the Foreign distribution to Canada.