Olympus Corporation of the Americas: Medical Device Recall in 2022 - (Recall #: Z-0551-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00

Product Classification:

Class II

Date Initiated: December 23, 2021

Date Posted: February 9, 2022

Recall Number: Z-0551-2022

Event ID: 89333

Reason for Recall:

Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)

Status: Ongoing

Product Quantity: 35 units

Code Information:

Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024

Distribution Pattern:

US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.

Voluntary or Mandated:

Voluntary: Firm initiated