FDA DeviceClass IINotable

FDA Recall: PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

Date: 2026-06-10
Brand: Oculus Technologies of Mexico, S.A. de C.V.
Category: Medical Device
FDA Class: Class II

Description

The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.

Hazard

The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.

Remedy

5904 units

View original recall →
Share:

Related Recalls

2026-06-10 · FDA_DEVICE
FDA Recall: BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in.; lidocaine H
Becton Dickinson & Company
2026-06-10 · FDA_DEVICE
FDA Recall: BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
CareFusion 303, Inc.
2026-06-10 · FDA_DEVICE
FDA Recall: Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 an
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2026-06-10 · FDA_DEVICE
FDA Recall: Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10
Kico Knee Innovation Company