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.
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 7
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Product code: BC0524A; All lots manufactured after March 1, 2011
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
device · product 2 of 7
Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Product code: BC0724A; All lots manufactured after March 1, 2011
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
device · product 3 of 7
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Product code: BC8524A; All lots manufactured after March 1, 2011
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
device · product 4 of 7
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Product code: BC1040A; All lots manufactured after March 1, 2011
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
device · product 5 of 7
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Product code: BC1240A; All lots manufactured after March 1, 2011
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
device · product 6 of 7
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Product code: BC1440A; All lots manufactured after March 1, 2011
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
device · product 7 of 7
Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Product code: BC1640A; All lots manufactured after March 1, 2011
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
