Aomori Olympus Co., Ltd.: Medical Device Recall in 2021 - (Recall #: Z-0964-2021)

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:

B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.

Product Classification:

Class II

Date Initiated: January 4, 2021

Date Posted: February 17, 2021

Recall Number: Z-0964-2021

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, 02K, 03K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated