CLASS II Device recall · Reported 30 Mar 2022 · FDA Enforcement Report

Compella Therapy Air Supply Unit recalled by Baxter Healthcare

Baxter Healthcare is recalling Compella Therapy Air Supply Unit, distributed nationwide in the US. The recall was initiated on 14 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803

Quantity recalled6022 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0821-2022
FDA event ID: 89644
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 14 Feb 2022
FDA classified: 23 Mar 2022
Reported: 30 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Feb 2022	Recall initiated by company
23 Mar 2022	Classified by FDA	+37 days
30 Mar 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Compella Therapy Air Supply Unit

Where it was distributed

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.

Nationwide Georgia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

All lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 89644

Reported	Class	Recall	Company	Reason	Where
30 Mar 2022	CLASS II	Compella Bariatric Bed System recalled by Baxter Healthcare	Baxter Healthcare	Other	Nationwide

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