Medivance recalls

2 official recalls and safety alerts involving Medivance since 2024-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Medivance or the relevant agency.

1. 2024-08-07
2. US
   Drugs & medicalClass II

   Medivance Inc. recalls Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun…

   If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air…

   FDA · DeviceMedivance Inc.Worldwide - US Nationwide distribution including in the states of IN, OK, MO,…Official notice →
3. 2024-04-03
4. US
   Drugs & medicalClass II

   Medivance Inc. recalls Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

   Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.

   FDA · DeviceMedivance Inc.Worldwide - US Nationwide distribution including in the states of IL, AL, AZ,…Official notice →