CompellaSurface recallZ-0821-2022 · Baxter Healthcare Corporation · initiated Feb 14, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Labeling design
What the company is doing
Customer notification letters were mailed beginning 02/21/2022. A localized customer letter will be mailed (with signature service) to all first-level consignees by Sedgwick. The letter will inform the customer of the issue, reason for Field Action and provide risk mitigations. The customer will be instructed to sign acknowledgement form to confirm receipt and return to a dedicated email address. Distributors will be asked to forward to their end users. Distributors will be provided with instructions on communication with their end users. All consignees will be required to return a signed acknowledgment form and confirm that they read and understand the issue. Distributors will be asked to forward to their end users. Distributors will be provided instruction on communication with their end users.
Recall details
- Recall number
- Z-0821-2022
- Status
- Terminated
- Initiated by the company
- Feb 14, 2022
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 6022 units
- Product code
- IOQ
- Distribution
- 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.
Product description
Compella Therapy Air Supply Unit
Code information (models, lots, serial numbers)
All lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Compella™Surface P7810AHill-Rom, Inc. · BED, FLOTATION THERAPY, POWERED1 recall82 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89644).
- Z-0820-2022 · TerminatedCompella Bariatric Bed System
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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