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 5
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
device · product 2 of 5
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
device · product 3 of 5
Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Due to convenience kits containing a kit component that is under a recall action for improper use.
Code information
Catalog Number: AMS11480 UDI-DI code: B098AMS114800 Lot Numbers: 205273
Distribution pattern
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
device · product 4 of 5
Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Due to convenience kits containing a kit component that is under a recall action for improper use.
Code information
Catalog Number: AMS11482 UDI-DI code: B098AMS114820 Lot Numbers: 205275
Distribution pattern
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
device · product 5 of 5
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
