DeVilbiss 1025UKRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K071397); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 9, 2023Open, Classified

   The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.

   Z-1558-2023 · Root cause: Labeling design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071397. One submission often covers many models, so check the product and lot details in each record.

• Z-1727-2025 · Apr 11, 2025 · Open, Classified
  iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
• Z-0724-2023 · Nov 18, 2022 · Open, Classified
  DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q