Home › Device types › DWJ
System, Thermal Regulating
FDA product code DWJ · Class 2 · Cardiovascular
0
Registered devices
26,819
Adverse events
70
Recalls
161
510(k) clearances
Devices with this code
3M™ Bair Hugger™ — 3M COMPANYSoft Air — ADROIT MEDICAL SYSTEMS, INC.PremierPro — PRESTIGE AMERITECH, LTD.KoZee Warming Blanket — Jiangmen Dacheng Medical Equipment Co., Ltd.Level 1 — ICU MEDICAL, INC.ThermoWrap™ Universal 79–91cm (single) — BELMONT INSTRUMENT CORPORATIONNova — Encompass Group, L.L.C.Koala — INSPIRATION HEALTHCARE GROUP PLCArctic Sun® Temperature Management System, Fill Tube — Medivance, Inc.PremierPro — PRESTIGE AMERITECH, LTD.3M™ Bair Hugger™ — 3M COMPANYIOB — Jiangmen Dacheng Medical Equipment Co., Ltd.PremierPro — PRESTIGE AMERITECH, LTD.NA — Hangzhou Tappa Medical Technology Co., Ltd.NA — Hangzhou Tappa Medical Technology Co., Ltd.Cocoon — CARE ESSENTIALS PTY LTDDeRoyal — DEROYAL INDUSTRIES, INC.FilteredFlo Warming Blanket — Jiangmen Dacheng Medical Equipment Co., Ltd.Cocoon — CARE ESSENTIALS PTY LTDIOB — Iob Medical Inc.PremierPro — PRESTIGE AMERITECH, LTD.Insulated Colder Connector — STRYKER CORPORATIONMistral-Air — The Surgical Company International B.V.3M™ Bair Hugger™ — 3M COMPANY
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | Gentherm Medical, LLC | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the dev |
| 2026-07-13 | Gentherm Medical, LLC | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the dev |
| 2026-07-13 | Gentherm Medical, LLC | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the dev |
| 2025-05-13 | Belmont Instrument LLC | An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sens |
| 2024-12-16 | Augustine Temperature Management, LLC | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connect |
| 2024-12-16 | Augustine Temperature Management, LLC | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connect |
| 2024-12-16 | Augustine Temperature Management, LLC | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connect |
| 2024-12-04 | Augustine Temperature Management, LLC | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to |
| 2024-12-04 | Augustine Temperature Management, LLC | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to |
| 2024-12-04 | Augustine Temperature Management, LLC | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to |
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