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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89644

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 14, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Baxter Healthcare Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Compella Bariatric Bed System

Z-0820-2022
Recall number
Z-0820-2022
Initiated
February 14, 2022
Classification
Class II
Status
Terminated
Quantity
5186 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

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.

device · product 2 of 2

Compella Therapy Air Supply Unit

Z-0821-2022
Recall number
Z-0821-2022
Initiated
February 14, 2022
Classification
Class II
Status
Terminated
Quantity
6022 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

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.

Field note

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