Atrium Medical Recalls Oasis Blood Recovery Drains Due to Sterility Issues
Atrium Medical is recalling Oasis Blood Recovery Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a packaging sterility issue without reported adverse events, fitting the criteria for a moderate severity score.
Plain-English summary
Atrium Medical Corporation is recalling specific Oasis Blood Recovery Drains, including models 3650-100 and 3652-100. These medical devices are used to evacuate air and fluid from the chest cavity or mediastinum, help re-establish lung expansion, and facilitate the collection and reinfusion of autologous blood. The recall is being conducted because the outer packaging of these devices is not sterile.
The recall affects all lot numbers with expiration dates prior to October 2019. The affected products were distributed worldwide, including nationwide in the United States and in numerous other countries such as Australia, Canada, China, France, Germany, and the United Kingdom. The total quantity involved is 964,463 cases in the US and 521,975 cases outside the US.
Healthcare facilities and consumers who have these specific blood recovery drains should stop using them and contact Atrium Medical Corporation for further instructions on how to return or dispose of the products.
The recalled product
- Product
- Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line connector 3652-100 Oasis Double Blood Recovery drain with in-line connectors - 2 patient lines connected by one Y connector Product Usage: To evacuate air and/or fluid f
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Surgical Drains
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lot Numbers With Expiration Date Prior To October 2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · Atrium Medical Corporation
See all →- ModerateiCast Covered Stent Recalled for Unique Device Identifier Labeling Error
FDA (Devices) · 2024-10-16
- HighVascular graft separation reported in ADVANTA VXT medical devices
FDA (Devices) · 2024-06-12
- HighVascular graft recalled due to slider component separation risk
FDA (Devices) · 2024-06-12
- HighVascular graft devices recalled due to slider component separation
FDA (Devices) · 2024-06-12
- HighVascular graft component separation reported in ADVANTA VXT devices
FDA (Devices) · 2024-06-12
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29