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 8
Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
These labels are deterministic app interpretations, not FDA categories.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Code information
23076, 25396, 26210, and 27186
Distribution pattern
Distributed in Texas and Louisiana.
device · product 2 of 8
Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
These labels are deterministic app interpretations, not FDA categories.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Code information
19215, 19570, 20849, 22557, 23871, 25469, and 27185
Distribution pattern
Distributed in Texas and Louisiana.
device · product 3 of 8
Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
These labels are deterministic app interpretations, not FDA categories.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Code information
24641
Distribution pattern
Distributed in Texas and Louisiana.
device · product 4 of 8
Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
These labels are deterministic app interpretations, not FDA categories.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Code information
22404, 23406, 23642, and 24032
Distribution pattern
Distributed in Texas and Louisiana.
device · product 5 of 8
Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
These labels are deterministic app interpretations, not FDA categories.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Code information
19532, 27389, 24399, and 24478
Distribution pattern
Distributed in Texas and Louisiana.
device · product 6 of 8
Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
These labels are deterministic app interpretations, not FDA categories.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Code information
26550
Distribution pattern
Distributed in Texas and Louisiana.
device · product 7 of 8
Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
These labels are deterministic app interpretations, not FDA categories.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Code information
19345
Distribution pattern
Distributed in Texas and Louisiana.
device · product 8 of 8
Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
These labels are deterministic app interpretations, not FDA categories.
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
