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
Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area.
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Code information
Lot Number: 242896, 243292
Distribution pattern
Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
device · product 2 of 7
Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Code information
Lot Number: 242897
Distribution pattern
Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
device · product 3 of 7
Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Code information
Lot Number: 242909, 242910, 242912, 242914, 242915
Distribution pattern
Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
device · product 4 of 7
Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Code information
Lot Number: 242919, 242920
Distribution pattern
Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
device · product 5 of 7
Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Code information
Lot Number: 243295
Distribution pattern
Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
device · product 6 of 7
Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Code information
Lot Number: 243842
Distribution pattern
Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
device · product 7 of 7
Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area
