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 9
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Code information
Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
device · product 2 of 9
Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Code information
Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers). To evacuate air and/or fluid from the chest cavity or mediastinum.
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
device · product 3 of 9
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Code information
Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
device · product 4 of 9
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Code: 2052-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Code information
Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
device · product 5 of 9
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Code information
Lot number starting with 10883097 and the ending lot number 10913346. ( All units in between and including these two numbers)
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
device · product 6 of 9
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Code information
Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
device · product 7 of 9
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Code information
Lot number starting with 10883097 and the ending lot number 10913346. All units in between and including these two numbers.
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
device · product 8 of 9
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Code information
Lot number starting with 10883097 and the ending lot number 10913346 (All units in between and including these two numbers)
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
device · product 9 of 9
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Code information
Lot number starting with 10883097 and the ending lot number 10913346 (All units in between and including these two numbers)
Distribution pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
