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STERIS CORPORATION · Model Patient Warming System · UDI-DI 00724995194208
DWJ
Prescription
10
510(k) clearances
26,819
Adverse events (54 deaths)
70
Recalls
92
Facilities
Description
The STERIS Patient Warming System (PWS) uses a heated surgical table pad and optional overbody blanket immediately upon transfer to the surgical table to provide heat to the patient before, during or after procedures in the Operating Room.
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 device to shut down. |
| 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 device to shut down, |
| 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 device to shut down. |
| 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 Sensor Board is disconne |
| 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 connector cable on the matt |
| 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 connector cable on the matt |
| 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 connector cable on the matt |
| 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 Power-on self-test |
| 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 Power-on self-test |
| 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 Power-on self-test |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.