System, Thermal Regulating
FDA product code DWJ · Class II (moderate risk) · 21 CFR 870.5900 · Cardiovascular
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
161510(k) clearances
0PMA approvals
66recalls
Manufacturers
- Augustine Medical, Inc. 12
- Medivance, Inc. 10
- Cincinnati Sub-Zero Products Inc 9
- Mtre Advanced Technology , Ltd. 6
- Gaymar Industries, Inc. 6
- Seabrook Medical Systems, Inc. 5
- Iob Medical, Inc. 5
- Smiths Medical ASD Inc. 4
- Augustine Biomedical & Design, LLC 4
- Augustine Temperature Management, LLC 4
- Progressive Dynamics, Inc. 4
- Thermogear, Inc. 3
- Gorman Rupp Industries 3
- Arizant Healthcare, Inc. 3
- 3M Company 3
- Care Essentials Pty, Ltd. 3
- Stryker Medical 3
- Klimamed Technologie Medizingerate GmbH 2
- Rg Ent., Inc. 2
- Avacore Technologies, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262089 | Disposable Warming BlanketDWJ · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 08/21/2026SE |
| K261437 | Mistral-Air® Warming SystemDWJ · Special | The Surgical Company International B.V., doing… | 08/07/2026SE |
| K260278 | ThermAffyx(TM) Patient Safety SystemDWJ · Traditional | Stihler Electronic GmbH | 07/08/2026SE |
| K260903 | Hot Pink Pad Warming SystemDWJ · Traditional | Xodus Medical, Inc. | 04/16/2026SE |
| K252861 | Warming SystemDWJ · Traditional | Hangzhou Tappa Medical Technology Co., Ltd. | 04/07/2026SE |
| K251974 | Arctic Sun Temperature Management System (Model 5000)DWJ · Traditional | Medivance, Inc. | 10/24/2025SE |
| K242964 | Celsi WarmerDWJ · Traditional | Hadleigh Health Technologies | 06/20/2025SE |
| K243942 | Arctic Sun Stat Temperature Management SystemDWJ · Traditional | Medivance, Inc. | 04/30/2025SE |
| K232627 | HotDog Warming Mattress + Return ElectrodeDWJ · Special | Augustine Temperature Management, LLC | 04/18/2024SE |
| K232502 | Cocoon Convective Warming System, Model CWS7000DWJ · Traditional | Care Essentials Pty, Ltd. | 02/21/2024SE |
| K231211 | Medline ComfortTemp Patient Warming SystemDWJ · Traditional | Medline Industries, LP | 12/01/2023SE |
| K232638 | FilteredFlo Warming BlanketsDWJ · Traditional | Iob Medical, Inc. | 10/24/2023SE |
| K232844 | The IQoolTM SystemDWJ · Special | Braincool AB | 10/04/2023SE |
| K232508 | Barrier EasyWarm Active Self-Warming BlanketDWJ · Special | Molnlycke Health Care Us, LLC | 09/15/2023SE |
| K231596 | IOB Temperature Management SystemDWJ · Traditional | Iob Medical, Inc. | 06/30/2023SE |
| K230866 | HotDog Warming Mattress + Return ElectrodeDWJ · Traditional | Augustine Temperature Management, LLC | 06/29/2023SE |
| K221669 | IOB Warming BlanketsDWJ · Traditional | Iob Medical, Inc. | 12/27/2022SE |
| K220941 | HotDog Temperature Management SystemDWJ · Traditional | Augustine Temperature Management | 09/23/2022SE |
| K210605 | 3M Bair Hugger Universal Warming Gown made with Thinsulate InsulationDWJ · Traditional | 3M Company | 04/29/2021SE |
| K210603 | 3M Bair Hugger Temperature Management System (Model 675)DWJ · Special | 3M Company | 03/30/2021SE |
| K203085 | NOVA Patient Warming SystemDWJ · Traditional | Encompass Group, LLC | 11/12/2020SE |
| K201779 | HotDog Temperature Management ControllerDWJ · Special | Augustine Temperature Management | 09/11/2020SE |
| K202197 | Astopad Patient Warming SystemDWJ · Traditional | Stihler Electronic GmbH | 09/04/2020SE |
| K200446 | STERIS Patient Warming SystemDWJ · Abbreviated | STERIS Corporation | 06/13/2020SE |
| K200225 | Arctic Sun Stat Temperature Management SystemDWJ · Special | Medivance, Inc. | 02/28/2020SE |
| K190221 | IOB Warming BlanketsDWJ · Traditional | Iob Medical, Inc. | 10/25/2019SE |
| K181671 | Cocoon Convective Warming SystemDWJ · Special | Care Essentials Pty, Ltd. | 05/02/2019SE |
| K180834 | Altrix Precision Temperature Management SystemDWJ · Traditional | Stryker Medical | 08/10/2018SE |
| K181699 | Level 1 Convective WarmerDWJ · Traditional | Smiths Medical Asd, Inc. | 07/26/2018SE |
| K180375 | The IQoolTM Warm SystemDWJ · Traditional | Braincool AB | 05/18/2018SE |
| K171373 | 3M Bair Hugger Model 675 Total Temperature Management SystemDWJ · Traditional | 3M Company | 10/10/2017SE |
| K171149 | Altrix Temperature Management WrapsDWJ · Traditional | Stryker Medical | 07/18/2017SE |
| K171234 | Mistral-Air Warming UnitDWJ · Special | The Surgical Company International BV (As the… | 05/26/2017SE |
| K162679 | IOB Temperature Management SystemDWJ · Traditional | Iob Medical, Inc. | 04/28/2017SE |
| K162562 | Opt-Shield Air, Supine; Opt-Shield, LithotomyDWJ · Traditional | Bcg Medical, LLC | 03/17/2017SE |
| K152266 | Altrix Precision Temperature Management SystemDWJ · Traditional | Stryker Medical | 12/02/2016SE |
| K161602 | Arctic Sun Temperature Management SystemDWJ · Special | Medivance, Inc. | 09/02/2016SE |
| K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and…DWJ · Traditional | Medivance, Inc. | 12/18/2014SE |
| K140078 | Tecotherm Neo (T Neo)DWJ · Abbreviated | Inspiration Healthcare, Ltd. | 11/14/2014SE |
| K141686 | Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…DWJ · Traditional | Smith Medical Asd, Inc. | 10/28/2014SE |
| K140635 | Cocoon Convective Warming SystemDWJ · Traditional | Care Essentials Pty, Ltd. | 07/25/2014SE |
| K132048 | Barrier Easywarm Active Self-Warming BlanketDWJ · Traditional | Molnlycke Health Care Us, LLC | 11/06/2013SE |
| K132454 | Vitaheat Patient Warming SystemDWJ · Traditional | Vitaheat Medical, LLC | 10/04/2013SE |
| K131361 | Warmtouch Surgical Access Blanket, Warmtouch Torso BlanketDWJ · Traditional | Covidien | 07/29/2013SE |
| K123083 | Covidien Warmtouch Convective Warming UnitDWJ · Traditional | Covidien | 04/17/2013SE |
| K123946 | Warmair Model 135 Hyperthermia System Including Filteredflo BlanketsDWJ · Special | Cincinnati Sub-Zero Products, Inc. | 01/17/2013SE |
| K113705 | Pintler Patient Warming SystemDWJ · Traditional | Pintler Medical | 08/31/2012SE |
| K121720 | Welkins Emt/Icu Temperature Managerment SystemDWJ · Traditional | Welkins, LLC | 08/20/2012SE |
| K120849 | Hybrid Arcticgel PadDWJ · Traditional | Medivance, Inc. | 07/20/2012SE |
| K121669 | Warmair Model 135 Hyperthermia System (Controller and Blankets)DWJ · Special | Cincinnati Sub-Zero Products, Inc. | 07/03/2012SE |
| K120081 | Norm-O-Temp Hyperthermia System Incliding Blankets/PadsDWJ · Traditional | Cincinnati Sub-Zero Products, Inc. | 02/17/2012SE |
| K112488 | Hotdog Patient Warming SystemDWJ · Traditional | Augustine Biomedical & Design, LLC | 11/23/2011SE |
| K102856 | Sirocco Thermal Regulating SystemDWJ · Traditional | Galmaz Biotech S.L. | 06/30/2011SE |
| K110104 | Blanketrol II Hyper-Hypothermia Temperature Managment SystemDWJ · Traditional | Cincinnati Sub-Zero Products, Inc. | 02/04/2011SE |
| K100585 | Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900DWJ · Traditional | Gaymar Industries, Inc. | 01/20/2011SE |
| K102112 | Criticool ProDWJ · Traditional | Mtre Advanced Technology , Ltd. | 11/18/2010SE |
| K093244 | Unique Temp Warming Blankets, Model 8001140XXXDWJ · Traditional | Geratherm Medical AG | 10/19/2010SE |
| K101148 | Warm Air Model 135 Hyperthermia System and BlanketsDWJ · Traditional | Cincinnati Sub-Zero Products, Inc. | 10/01/2010SE |
| K101589 | Blanketrol III, Model 233 and Coolblue, Model 25-01 Hyper-Hypothermia SystemsDWJ · Traditional | Cincinnati Sub-Zero Products, Inc. | 09/20/2010SE |
| K093694 | Geratherm UniquerescDWJ · Traditional | Geratherm Medical AG | 09/20/2010SE |
| K101092 | Arctic Sun Temperature Management System, Model 5000DWJ · Traditional | Medivance, Inc. | 07/16/2010SE |
| K101705 | Mistral-Air Warming SystemDWJ · Traditional | The Surgical Company International B.V. | 07/02/2010SE |
| K094056 | Hotdog Multi Function ControllerDWJ · Traditional | Augustine Biomedical & Design, LLC | 06/03/2010SE |
| K092807 | Hot Dog Patient Warming Mattress System, Models Wcub, M101, M102 and M103DWJ · Traditional | Augustine Biomedical & Design, LLC | 12/10/2009SE |
| K083336 | Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1…DWJ · Traditional | Smiths Medical Asd, Inc. | 06/03/2009SE |
| K083662 | CriticoolDWJ · Traditional | Mtre Advanced Technology , Ltd. | 03/26/2009SE |
| K083135 | Modification to Chillbuster Portable Electric Blanket , Model 8002DWJ · Traditional | Thermogear, Inc. | 10/31/2008SE |
| K073712 | Soft Air, Model SA 4000 and Mistral Air, Model MA0100DWJ · Traditional | Adroit Medical Systems, Inc. | 06/06/2008SE |
| K080763 | Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HTDWJ · Traditional | Talley Medical | 05/30/2008SE |
| K072513 | Dm-EmgDWJ · Traditional | Gvp Elettronica Srl | 12/07/2007SE |
| K071918 | Chillbuster Portable Electric Blanket, Model 8002DWJ · Traditional | Thermogear, Inc. | 11/09/2007SE |
| K071341 | Modification to Arctic Sun Temperature Management System, Model 2000DWJ · Special | Medivance, Inc. | 08/03/2007SE |
| K070112 | Rapidcool Patient Temperature Management SystemDWJ · Traditional | Medcool, Inc. | 07/13/2007SE |
| K061902 | Cosytherm, Models NCM1, NCM2, NCB1, CCU1, CRU1DWJ · Traditional | Inditherm Medical | 12/08/2006SE |
| K062794 | PRN Thermalcare, Model 3000DWJ · Traditional | American Healthcare Products, Inc. | 12/07/2006SE |
| K061513 | Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody BlanketDWJ · Traditional | Smiths Medical Asd, Inc. | 08/01/2006SE |
| K051336 | Geratherm Sos-Rescue BagDWJ · Traditional | R.G. Enterprises, Inc. | 06/29/2006SE |
| K051278 | Geratherm Sos-Vacutherm (Thermamed Smartcare)DWJ · Traditional | Rg Ent., Inc. | 06/29/2006SE |
| K052392 | Hot Dog Patient Warming SystemDWJ · Traditional | Augustine Biomedical & Design, LLC | 05/04/2006SE |
| K051419 | Inditherm Patient Warming System, Models MECU1; OTM1; OTM2; GTM1; PTM1; Otb; RB1DWJ · Traditional | Inditherm Medical | 04/27/2006SE |
| K060865 | Bair Paws Temperature Management System Model 850DWJ · Special | Arizant Healthcare, Inc. | 04/24/2006SE |
| K053645 | Modification To:Bair Hugger Temperature Management SystemsDWJ · Special | Arizant Healthcare, Inc. | 03/09/2006SE |
| K051097 | Geratherm Sos-Rescue BlanketDWJ · Traditional | Rg Ent., Inc. | 02/24/2006SE |
| K031728 | Klimamed Thermal Blankets, Including Arm Shoulder West Thermal Blanket and Leg Warmer…DWJ · Traditional | Klimamed Technologie Medizingerate GmbH | 10/12/2004SE |
| K041686 | Bair Hugger Temperature Management SystemDWJ · Special | Arizant Healthcare, Inc. | 06/30/2004SE |
| K040911 | VitalheatDWJ · Traditional | Dynatherm Medical, Inc. | 06/22/2004SE |
| K040632 | Snuggle Warm 4000 Convective Warming System, Model SW4000DWJ · Special | Smiths Medical Asd, Inc. | 04/27/2004SE |
| K040440 | HTTP System (HTTP 2001 Controller and HTTP Warm Me Blankets)DWJ · Traditional | Http Hypothermia Therapy | 04/27/2004SE |
| K033021 | Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer PadsDWJ · Traditional | Kimberly-Clark Corp. | 11/12/2003SE |
| K024128 | Allon 2001 Version 5DWJ · Special | Mtre Advanced Technology , Ltd. | 02/10/2003SE |
| K023934 | Rapid Thermal Exchange SystemDWJ · Traditional | Avacore Technologies, Inc. | 01/23/2003SE |
| K022903 | ChillbusterDWJ · Traditional | Microtek Medical, Inc. | 11/27/2002SE |
| K014210 | Palmo Thermoregulation Interface AccessoryDWJ · Traditional | Avacore Technologies, Inc. | 08/16/2002SE |
| K021473 | Bair Hugger Temperature Management SystemDWJ · Traditional | Augustine Medical, Inc. | 07/09/2002SE |
| K011859 | Klimamed Thermal Mat & Controller 95 and 55 WattsDWJ · Traditional | Klimamed Technologie Medizingerate GmbH | 05/01/2002SE |
| K020604 | Warmtouch Patient Warming System, Model 5300DWJ · Special | Nellcor Puritan Bennett, Inc. | 04/23/2002SE |
| K014121 | Warmtouch Cardiac Blanket,Catalog # 503-0860DWJ · Special | Nellcor Puritan Bennett, Inc. | 01/11/2002SE |
| K011907 | Snuggle Warm 4000 Convective Warming SystemDWJ · Traditional | Sims Level 1, Inc. | 12/18/2001SE |
| K010338 | Artic Sun Temperature Management System, Model 200DWJ · Special | Medivance, Inc. | 03/07/2001SE |
| K003368 | AcrothermDWJ · Traditional | Aquarius Medical Corp. | 01/19/2001SE |
| K003349 | Allon 2001 ModifiedDWJ · Special | Mtre Advanced Technology , Ltd. | 11/13/2000SE |
| K002577 | Arctic Sun Temperature Management System, Model 100 Control Unit and Patient Energy…DWJ · Traditional | Medivance, Inc. | 10/26/2000SE |
| K001149 | Augustine Medical Bair Huuger, Model 750 Total Temperature Management System-(Model 750…DWJ · Traditional | Augustine Medical, Inc. | 09/06/2000SE |
| K001546 | Allon 2001DWJ · Special | Mtre Advanced Technology , Ltd. | 06/08/2000SE |
| K981093 | Wesco BlanketDWJ · Traditional | Wesco, Inc. | 03/28/2000SE |
| K992386 | Allon 2000DWJ · Traditional | Mtre Advanced Technology , Ltd. | 03/07/2000SE |
| K991684 | Chillbuster Portable Electric Blanket System, Model 8001DWJ · Traditional | Thermogear, Inc. | 03/01/2000SE |
| K973705 | Contor Table SurfaceDWJ · Traditional | Hill-Rom, Inc. | 08/07/1998SE |
| K970367 | Thermo-Stat SystemDWJ · Traditional | Aquarius Medical Corp. | 12/17/1997SE |
| K964673 | Bair Hugger Model 630 Cardiac BlanketDWJ · Traditional | Augustine Medical, Inc. | 06/26/1997SE |
| K964377 | Thermal Regulation System BlanketDWJ · Traditional | Gibeck, Inc. | 04/23/1997SE |
| K963731 | TRU-5000 Thermal Recovery Radiant Heating UnitDWJ · Traditional | Enthermics Medical Systems, Inc. | 04/22/1997SE |
| K960511 | Gibeck Warmbag Reusable Convective Warming BlanketDWJ · Traditional | Gibeck, Inc. | 01/13/1997SE |
| K960167 | System, Thermal Regulating 74-DWJDWJ · Traditional | Augustine Medical, Inc. | 06/17/1996SE |
| K952329 | Life-Air 1000 Hypothermic Therapy SystemDWJ · Traditional | Progressive Dynamics, Inc. | 01/17/1996SE |
| K952864 | Bair Hugger Model 655 BlanketDWJ · Traditional | Augustine Medical, Inc. | 09/12/1995SE |
| K952086 | Tropicair Convective Warming BlanketsDWJ · Traditional | Seabrook Medical Systems, Inc. | 09/06/1995SE |
| K946196 | Tropicair Convective Waring SystemDWJ · Traditional | Seabrook Medical Systems, Inc. | 09/06/1995SE |
| K950416 | Bair Hugger Model 600 Unit, BlanketsDWJ · Traditional | Augustine Medical, Inc. | 08/29/1995SE |
| K942881 | TC 3000DWJ · Traditional | Gaymar Industries, Inc. | 05/23/1995SE |
| K942790 | Warm Air Hypertheermia System (Models #130 and #133)DWJ · Traditional | Cincinnati Sub-Zero Products, Inc. | 01/24/1995SE |
| K942599 | Warm Air Warming UnitDWJ · Traditional | Cincinnati Sub-Zero Products, Inc. | 01/24/1995SE |
| K943276 | Warmtouch Plastic Warming CoverDWJ · Traditional | Mallinckrodt Medical | 09/19/1994SE |
| K940171 | Cabot Medical Niagra-Trs Thermal Retention SystemDWJ · Traditional | Cabot Medical Corp. | 03/09/1994SE |
| K933764 | Life-Air 1000 Patient Warming CoverDWJ · Traditional | Progressive Dynamics, Inc. | 11/09/1993SE |
| K930345 | TC2000 Power Unit and AccessoriesDWJ · Traditional | Gaymar Industries, Inc. | 08/06/1993SE |
| K923104 | Tropic-AirDWJ · Traditional | Seabrook Medical Systems, Inc. | 07/13/1993SE |
| K921920 | Soft-TempDWJ · Traditional | Adroit Medical Systems, Inc. | 12/11/1992SE |
| K921165 | Bair Hugger Torso Blanket - Arms in Model 540DWJ · Traditional | Augustine Medical, Inc. | 08/06/1992SE |
| K920432 | Bair Hugger Cub Blanket- Short Model 536DWJ · Traditional | Augustine Medical, Inc. | 06/18/1992SE |
| K914382 | Life-Air 1000 Hypothermic Treatment SystemDWJ · Traditional | Progressive Dynamics, Inc. | 04/21/1992SE |
| K914383 | Life-Air 1000 Patient Warming CoversDWJ · Traditional | Progressive Dynamics, Inc. | 03/30/1992SE |
| K920265 | Bair Hugger Patient Warming SystemDWJ · Traditional | Augustine Medical, Inc. | 03/27/1992SE |
| K914805 | TC-1000, TC-1050 SystemDWJ · Traditional | Gaymar Industries, Inc. | 01/07/1992SE |
| K913734 | Bair Hugger(R) Patient Warm Syst/Baby Warm CoverDWJ · Traditional | Augustine Medical, Inc. | 10/23/1991SE |
| K913016 | WarmtouchDWJ · Traditional | Advanced Warming Systems, Inc. | 09/04/1991SE |
| K912051 | Medi-Therm (MTA-5900) & Detachable HosesDWJ · Traditional | Gaymar Industries, Inc. | 07/30/1991SE |
| K910327 | Warmair SystemDWJ · Traditional | Cincinnati Sub-Zero Products, Inc. | 05/16/1991SE |
| K904690 | Temp Marq(Tm) Convective Warming SystemDWJ · Traditional | Marquest Medical Products, Inc. | 02/01/1991SE |
| K902650 | BodyheatDWJ · Traditional | Medadvances, Inc. | 12/20/1990SE |
| K902756 | Tropi-CoolDWJ · Traditional | Seabrook Medical Systems, Inc. | 10/22/1990SE |
| K903360 | Bair Hugger(R) Patient Warming System-ModificationDWJ · Traditional | Augustine Medical, Inc. | 08/14/1990SE |
| K900186 | Bonchek-Shiley Cardiac Jacket W/Recirculation SetDWJ · Traditional | Shiley, Inc. | 04/10/1990SE |
| K894980 | Bio-Cal 370 Heater/CoolerDWJ · Traditional | Bio Medicus, Inc. | 11/02/1989SE |
| K890575 | Accutherm PTS-200DWJ · Traditional | Medical Repackers Co. | 05/05/1989SE |
| K882442 | RK2000 K-Thermia SystemDWJ · Traditional | Baxter Healthcare Corp | 09/06/1988SE |
| K882035 | Heart-Chill Saline Slush PadDWJ · Traditional | Buckman Co., Inc. | 07/28/1988SE |
| K881322 | Mini-Temp(Tm)DWJ · Traditional | Seabrook Medical Systems, Inc. | 06/22/1988SE |
| K873546 | Ves-Temp Model VT1 Monoplace Cool/Heat SystemDWJ · Traditional | Reimers Engineering, Inc. | 01/29/1988SE |
| K873745 | Bair Hugger(Tm) - Patient Warming SystemDWJ · Traditional | Augustine Medical, Inc. | 11/06/1987SE |
| K854856 | Thermorite Model HC-83 Hypo/Hyperthermia UnitDWJ · Traditional | Thermorite, Inc. | 06/02/1986SE |
| K820814 | Thermo-KDWJ · Traditional | American Medical Systems, Inc. | 04/29/1982SE |
| K812955 | East Water Unit Mark 3DWJ · Traditional | Cairco , Ltd. | 12/29/1981SE |
| K811742 | Hemotherm Model 400DWJ · Traditional | Cincinnati Sub-Zero | 08/13/1981SE |
| K811743 | MaxithermDWJ · Traditional | Cincinnati Sub-Zero | 07/16/1981SE |
| K801253 | Crest Electronic Warming BlanketDWJ · Traditional | Penlon, Inc. | 01/02/1981SE |
| K800812 | Medi-ThermDWJ · Traditional | Gaymar Industries, Inc. | 04/24/1980SE |
| K772015 | Patient Heater System, Model PH112DWJ · Traditional | Carolina Medical Electronics | 11/15/1977SE |
| K771537 | Aquamatic K-Module Model K-20DWJ · Traditional | Gorman Rupp Industries | 09/06/1977SE |
| K770839 | Aquamatic K-77DWJ · Traditional | Gorman Rupp Industries | 06/08/1977SE |
| K761087 | Electronic Control UnitDWJ · Traditional | Gorman Rupp Industries | 12/06/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2970-2026 Class II | Blanketrol III, Model 233; Thermal regulating system.Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and… | Gentherm Medical, LLC | 07/13/2026Open, Classified |
| Z-2969-2026 Class II | Innercool Coolblue Console, Model STx; Thermal regulating system.Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and… | Gentherm Medical, LLC | 07/13/2026Open, Classified |
| Z-2968-2026 Class II | Blanketrol II Model 222S; Thermal regulating system.Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and… | Gentherm Medical, LLC | 07/13/2026Open, Classified |
| Z-1966-2025 Class II | Allon 2001. Part Number: 200-00263An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the… | Belmont Instrument LLC | 05/13/2025Open, Classified |
| Z-1199-2025 Class II | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF…There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It… | Augustine Temperature Management, LLC | 12/16/2024Open, Classified |
| Z-1198-2025 Class II | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50")…There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It… | Augustine Temperature Management, LLC | 12/16/2024Open, Classified |
| Z-1197-2025 Class II | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF…There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It… | Augustine Temperature Management, LLC | 12/16/2024Open, Classified |
| Z-0702-2025 Class II | Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with…Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature… | Augustine Temperature Management, LLC | 12/04/2024Open, Classified |
| Z-0701-2025 Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller…Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature… | Augustine Temperature Management, LLC | 12/04/2024Open, Classified |
| Z-0700-2025 Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller…Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature… | Augustine Temperature Management, LLC | 12/04/2024Open, Classified |
| Z-2457-2024 Class II | Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00…If temperature management system fails to reach correct target water temperature while device is operating… | Medivance Inc. | 06/27/2024Open, Classified |
| Z-1381-2024 Class II | Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802CNeonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling… | Medivance Inc. | 02/16/2024Open, Classified |
| Z-1172-2025 Class II | Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138…Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact . | Augustine Temperature Management, LLC | 02/15/2024Open, Classified |
| Z-1171-2025 Class II | Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136…Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact . | Augustine Temperature Management, LLC | 02/15/2024Open, Classified |
| Z-0843-2025 Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller…HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model… | Augustine Temperature Management, LLC | 03/14/2022Completed |
| Z-0842-2025 Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller…HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model… | Augustine Temperature Management, LLC | 03/14/2022Completed |
| Z-0841-2025 Class II | Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with…HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model… | Augustine Temperature Management, LLC | 03/14/2022Completed |
| Z-0840-2025 Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller…HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model… | Augustine Temperature Management, LLC | 03/14/2022Completed |
| Z-0839-2025 Class II | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller…HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model… | Augustine Temperature Management, LLC | 03/14/2022Completed |
| Z-0153-2023 Class II | CritiCool, thermoregulation devicePremature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot… | Belmont Instrument Corporation | 07/20/2021Open, Classified |
| Z-0987-2020 Class II | Cocoon Convective Warming System, Product Code: CWS5000 (110V).Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper… | Care Essentials Pty., Ltd. | 01/07/2020Terminated |
| Z-0986-2020 Class II | Cocoon Convective Warming System, Product Code: CWS4000 (110V).Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper… | Care Essentials Pty., Ltd. | 01/07/2020Terminated |
| Z-0419-2020 Class II | CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool - Product…Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage.… | Cincinnati Sub-Zero Products LLC, a… | 07/02/2019Terminated |
| Z-0418-2020 Class II | Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system…Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage.… | Cincinnati Sub-Zero Products LLC, a… | 07/02/2019Terminated |
| Z-0417-2020 Class II | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature management…Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage.… | Cincinnati Sub-Zero Products LLC, a… | 07/02/2019Terminated |
| Z-2356-2019 Class II | Norm-O-Temp model 111WThe manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause… | Cincinnati Sub-Zero Products LLC, a… | 06/20/2019Terminated |
| Z-2355-2019 Class II | Norm-O-Temp model 111ZThe manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause… | Cincinnati Sub-Zero Products LLC, a… | 06/20/2019Terminated |
| Z-0235-2019 Class II | Altrix Precision Temperature Management System Model: 8001Product Usage: The Altrix…Users may experience alarm fatigue due to frequent alarming relating to patient temperature deviation beyond… | Stryker Medical Division of Stryker… | 09/06/2018Terminated |
| Z-0362-2020 Class II | TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20…The action is being initiated due to potential installation of faulty peltier-elements within the… | Tec Com Gmbh | 08/14/2018Terminated |
| Z-2536-2018 Class II | Arctic Sun Temperature Management System, Model 5000. The Arctic Sun 5000 model is a…An improper wiring connection on the chiller assembly may result in overheating of the connection and… | Bard Medical Division | 06/13/2018Terminated |
| Z-1139-2019 Class II | A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad. PPWS-001…Malfunction warming pad. | Pintler Medical LLC | 04/20/2018Completed |
| Z-0900-2018 Class II | BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO…Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and… | Medtronic Perfusion Systems | 02/08/2018Terminated |
| Z-0599-2018 Class II | 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M…Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can… | 3M Company - Health Care Business | 01/23/2018Terminated |
| Z-0598-2018 Class II | 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500…Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can… | 3M Company - Health Care Business | 01/23/2018Terminated |
| Z-1241-2019 Class II | Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid…Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the… | Bard Medical Division | 11/08/2017Terminated |
| Z-0271-2018 Class II | Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains…Hydrogel peeling from the pads. | C.R. Bard, Inc. | 10/16/2017Terminated |
| Z-0419-2018 Class II | MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG…It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a… | Stryker Medical Division of Stryker… | 07/21/2017Terminated |
| Z-0590-2018 Class III | Arctic Sun ArcticGel Pads - Medium, Product Code 317-07Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the… | C.R. Bard, Inc. | 06/02/2017Open, Classified |
| Z-3042-2017 Class II | Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V USPotential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is… | C.R. Bard, Inc. | 03/31/2017Terminated |
| Z-2058-2017 Class II | Medi-Therm Hyper/Hypothermia System, MTA7900The water may reheat too quickly if the unit is in "Automatic" mode, switched to "Manual" mode to view water… | Stryker Medical Division of Stryker… | 03/29/2017Terminated |
| Z-2345-2016 Class III | Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and…An internal review of an available product found that the Information For Use only contained English and… | C.R. Bard, Inc. | 06/30/2016Terminated |
| Z-1395-2016 Class II | BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is…Complaints were received of restricted/inaccurate flow rate. | C.R. Bard, Inc. | 03/04/2016Terminated |
| Z-0760-2016 Class II | Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient…Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was… | C.R. Bard, Inc. | 11/10/2015Terminated |
| Z-1617-2016 Class II | Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a…The product may contain electronic components that lead to a premature drainage of the internal control… | C.R. Bard, Inc. | 11/09/2015Terminated |
| Z-1650-2014 Class II | SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator…The hose could separate from the blanket. | Smiths Medical ASD, Inc. | 04/22/2014Terminated |
| Z-1679-2014 Class II | 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a…The incorrect voltage component was placed into the device during manufacturing. This may make the device… | Cincinnati Sub-Zero Products Inc | 01/08/2014Terminated |
| Z-0933-2014 Class II | The Gaymar Medi-Therm device provides a means of regulating patient temperature by…Stryker Medical has identified that on some units of the MTA7900, there is a lack of a water temperature… | Stryker Medical Division of Stryker… | 12/27/2013Terminated |
| Z-2209-2013 Class II | Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller…During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Operations &… | Cincinnati Sub-Zero Products Inc | 09/03/2013Terminated |
| Z-0443-2014 Class II | Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software…During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was… | Cincinnati Sub-Zero Products Inc | 05/15/2013Terminated |
| Z-2181-2012 Class II | Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient…A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its… | Kimberly-Clark Corporation | 04/27/2012Terminated |