Atrium Medical Corporation: Medical Device Recall in 2024 - (Recall #: Z-0621-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.
Product Description:

Atrium Oasis Drain Single W / AC, Part No. 3600-100

Product Classification:

Class II

Date Initiated: November 1, 2023
Date Posted: January 3, 2024
Recall Number: Z-0621-2024
Event ID: 93553
Reason for Recall:

A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.

Status: Ongoing
Product Quantity: 835 cases total (6 units/case)
Code Information:

UDI-DI 00650862110012 Lots 492065 and 492075

Distribution Pattern:

Domestic distribution nationwide. No foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated