Lower risk Medical device recall · FDA · Published September 5, 2023

Atrium Oasis Dry Suction Water Seal Chest Drain Recall: Improper Sterilization Risk

Atrium Medical recalls Oasis Dry Suction Water Seal Chest Drains with part number 3650-100 due to improper sterilization process by a third party. Affected units include specific lots; contact for remedy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0486-2024Medical device Atrium Medical ›

Lower-risk recall

Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.

Take action

Contact the company

Recalling firmAtrium Medical Corporation40 Continental Blvd · Merrimack, NH 03054-4332

✎ GovInfoNow plain-language explainer

Atrium Medical is recalling certain Oasis Dry Suction Water Seal Chest Drains because they were re-sterilized using an unapproved method. This could lead to infection or other complications if the device is used improperly. Read more at govinfonow.com/recall/57383-atrium-oasis-dry-suction-water-seal-chest-drain-recall-improper.

Source Summary by GovInfoNow · govinfonow.com/recall/57383-atrium-oasis-dry-suction-water-seal-chest-drain-recall-improper · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0486-2024

Cite this page

“Atrium Oasis Dry Suction Water Seal Chest Drain Recall: Improper Sterilization Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/57383-atrium-oasis-dry-suction-water-seal-chest-drain-recall-improper. Based on FDA recall #Z-0486-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0486-2024%22&limit=1).

The FDA announced on 2023-09-05 that Atrium Medical Corporation is recalling specific lots of Atrium Oasis Dry Suction Water Seal Chest Drain units. The agency stated the devices were re-processed and re-sterilized by a third party using unapproved packaging and sterilization processes.

How to tell if you have it

Brand: Atrium Medical
Product: Atrium Oasis Dry Suction Water Seal Chest Drain, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Part Number: 3650-100
UDI-DI: 20650862113017
Lots: 461817, 467572, 468617, 468855, 467191, 467849, 469401, 479253
Distribution: US: VA

The hazard

The product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacturer and lack validation.

Context

GovInfoNow's records show Atrium Medical Corporation has 16 other recalls on record since 2017-11-22. Other recent recalls of similar products include Getinge Thoracic Catheter Recall (2026-08-07), Atrium Medical iCast Stent Recall (2024-09-09), and Atrium Medical FLIXENE Vascular Graft Recall (2024-05-03).

How to tell if you have this one

Check the product label for part number 3650-100. Look for lot numbers: 461817, 467572, 467849, 468617, 468855, 467191, 469401, 479253.

Brand
Atrium Medical
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US: VA

Recall number	Product, codes & lots	Quantity
Z-0485-2024	Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.; UDI-DI: 20650862110016. Lots: 460793, 461324, 463567, 463568, 463569, 466447, 466945, 466946, 467473, 467843, 471055, 471797, 472571, 474505, 477919, 480204, 480205, 480658, 482038, 483030, 483794, 484519, 484521, 484530, 486156, 486531, 487059, 488305, 489762.	—
Z-0486-2024	Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY; UDI-DI: 20650862113017. Lots: 461817, 467572, 467572, 468617, 468855, 467191, 467849, 469401, 479253.	—

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for part number 3650-100 and lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in Virginia.

FDA distribution: “US: VA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Virginia.

Recall timeline

FDA published this recall 3 months after the firm started it.

Sep 5, 2023Firm started the recall
Dec 1, 2023FDA classified it Class II
Dec 13, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Atrium Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/57383-atrium-oasis-dry-suction-water-seal-chest-drain-recall-improper">Atrium Oasis Dry Suction Water Seal Chest Drain Recall: Improper Sterilization Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0486-2024 (September 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0486-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.