The Recall Desk
HighFDA (Devices)·Z-0820-2022·Announced 2022-03-30

Compella Bariatric Bed System Recall—Power Cord Electrical Shock Risk

Baxter Healthcare is recalling the Compella Bariatric Bed System due to potential power cord damage that could expose electrical conductors, creating a shock hazard. Approximately 5186 units worldwide are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device with potential electrical shock hazard from power cord damage. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score as High (3).

Plain-English summary

Baxter Healthcare Corporation is recalling the Compella Bariatric Bed System due to potential power cord damage. The power cord may become damaged in a way that exposes electrical conductors, creating a risk of electrical shock from the power supply.

The recalled beds were distributed worldwide, including throughout the United States and to 35 additional countries. Approximately 5186 units have been identified in this recall. The affected product is identified by UDI 00887761000902.

The recalled product

Product
Compella Bariatric Bed System
Manufacturer
Baxter Healthcare Corporation
Hazard
  • electrical-shock
  • power-cord-damage

Distribution

Distributed nationwide across the United States.