Aomori Olympus Co., Ltd.: Medical Device Recall in 2021 - (Recall #: Z-0961-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.

Product Classification:

Class II

Date Initiated: January 4, 2021

Date Posted: February 17, 2021

Recall Number: Z-0961-2021

Event ID: 87074

Reason for Recall:

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Status: Terminated

Product Quantity: 7,400,000 (global); 260,395 (US)

Code Information:

01K, 03K, 04K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated