Home › Device types › DWJ
System, Thermal Regulating
FDA product code DWJ · Class 2 · Cardiovascular
1,103
Registered devices
26,610
Adverse events
70
Recalls
160
510(k) clearances
Devices with this code
IOB — Jiangmen Dacheng Medical Equipment Co., Ltd.KoZee Warming Blanket — Jiangmen Dacheng Medical Equipment Co., Ltd.Arctic Sun® Temperature Management System, Service Kit Model 5000 — Medivance, Inc.TECOtherm — Tec Com Medizintechnik GmbHKoZee Warming Blanket — Jiangmen Dacheng Medical Equipment Co., Ltd.Soft Air — ADROIT MEDICAL SYSTEMS, INC.NA — STRYKER CORPORATIONSoft Air — ADROIT MEDICAL SYSTEMS, INC.Solventum™ Bair Hugger™ — Solventum US LLCMistral-Air — The Surgical Company International B.V.Patient Warming Mattress — VITA HEAT MEDICALPremierPro — PRESTIGE AMERITECH, LTD.Bair Paws™ — 3M COMPANYASTOPAD® — Stihler Electronic GmbHKozee — SOURCEMARK, LLC.PremierPro — PRESTIGE AMERITECH, LTD.SourceMark — SOURCEMARK, LLC.Geratherm Medical Warming Systems — R.G. ENTERPRISES (U.S.A.), INC.IOB — Jiangmen Dacheng Medical Equipment Co., Ltd.Mistral-Air — The Surgical Company International B.V.3M™ Bair Hugger™ — 3M COMPANYBair Paws™ — 3M COMPANYPremierPro — PRESTIGE AMERITECH, LTD.Cocoon — CARE ESSENTIALS PTY LTD
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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