FDA (Devices) recall action 64625
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and clarify instructional steps.
Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling, add warnings, and clarify instructional steps.
Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and clarify instructional steps.
Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and clarify instructional steps.
Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling, add warnings, and clarify instructional steps.
Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and add warnings. The recall covers 2,366 units distributed in the US, Belgium, Canada, and Saudi Arabia.
Acclarent is recalling Inspira AIR Balloon Dilation Systems to correct labeling and add warnings. The recall covers 1,217 units distributed in the US, Belgium, Canada, and Saudi Arabia.