Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Recalled by Atrium Medical Corporation Due to Outer Packaging is not sterile
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Atrium Medical Corporation directly.
Affected Products
Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control stopcock 2050-300 Ocean Blood Recovery drain with suction control stopcock, no in-line connector 2052-000 Ocean Double Blood Recovery drain with in-line connector and suction control stopcock - 2 patient lines connected by one Y connector 2052-300 Ocean Double Blood Recovery drain with suction control stopcock, no in-line connector - 2 patient lines connected by one Y connector Product Usage: 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 patient s pleural cavity or mediastinal area.
Quantity: 964,463 cases (US) 521,975 cases (OUS) in total
Why Was This Recalled?
Outer Packaging is not sterile
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Atrium Medical Corporation
Atrium Medical Corporation has 150 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report