Z-0820-2022 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

FDA device recall Z-0820-2022 was initiated by Baxter Healthcare Corporation on Feb 14, 2022 and is designated Class II. Reason for recall: Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains. The recall status is terminated (terminated Jul 2, 2026). Affected quantity: 5186 units.

Recall Details

Product Type
Devices
Report Date
Mar 30, 2022
Initiation Date
Feb 14, 2022
Termination Date
Jul 2, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5186 units

Product Description

Compella Bariatric Bed System

Reason for Recall

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Cameroon, Canada, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Jamaica, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkmenistan, UAE, and UK.

Code Information

All lots/serial numbers UDI information: Compella Bariatric Bed - 00887761000902

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0820-2022
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.