Atrium Oasis surgical drain recalled for premature sterilization expiration
Atrium Oasis surgical drain recalled due to sterilization nonconformance that shortened the product's shelf life. Affected units were distributed nationwide and may not maintain sterility if used after November 17, 2025.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving loss of sterilization claim on a medical device with no reported illnesses or injuries to date. The theoretical risk of infection from using a non-sterile surgical drain after its true expiration date meets the High severity threshold.
Plain-English summary
Atrium Medical Corporation is recalling the Atrium Oasis Drain Single W / AC (Part No. 3600-100), a medical device drain used in healthcare settings. A total of 835 cases (6 units per case) have been distributed nationwide with UDI-DI 00650862110012.
A sterilization nonconformance during manufacturing prematurely aged the product by 48.3 days. This error resulted in the expiration date printed on product labels being inaccurate and not reflecting the true sterilization timeline of the affected units. The affected product lots are 492065 and 492075.
Use of the product after the true expiration date of November 17, 2025, creates an increased risk to patients and healthcare providers, as the sterile barrier of the device may be compromised. Healthcare facilities should immediately identify whether they have the affected product in stock using the lot numbers provided and take appropriate action to secure replacement units.
The recalled product
- Product
- Atrium Oasis Drain Single W / AC, Part No. 3600-100
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Surgical Drain
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)
- UDI-DI 00650862110012 Lots 492065 and 492075
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Atrium Medical Corporation
See all →- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- ModerateiCast Covered Stent Recalled for Unique Device Identifier Labeling Error
FDA (Devices) · 2024-10-16
- HighVascular graft component separation reported in Advanta VXT devices
FDA (Devices) · 2024-06-12
Same hazard · sterilization failure
See all →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- HighAtrium Oasis Chest Drain Recalled Due to Invalid Sterilization Process
FDA (Devices) · 2023-12-13
- HighAtrium Medical Oasis Single Drain Recalled for Non-Sterile Packaging
FDA (Devices) · 2017-02-01
- ModerateAtrium Medical Recalls Oasis Blood Recovery Drains Due to Sterility Issues
FDA (Devices) · 2017-02-01
- HighChest Drain Devices Re-sterilized Using Unapproved Process
FDA (Devices) · 2023-12-13
- HighAtrium Medical Recalls Oasis Chest Drains Due to Missing O-Ring
FDA (Devices) · 2015-07-08
- HighAtrium Medical Oasis Dual Chamber Drain Recall Due to Sterility Issue
FDA (Devices) · 2017-02-01