KooJoo Trading Company: Medical Device Recall in 2013 - (Recall #: Z-1729-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per case Blood collection by penetrating skin with needle.

Product Classification:

Class II

Date Initiated: July 3, 2013

Date Posted: July 24, 2013

Recall Number: Z-1729-2013

Event ID: 65664

Reason for Recall:

Lancets were not sterilized within the dose range established by sterilization validation.

Status: Terminated

Product Quantity: 7, 712, 000 pieces (1928 cartons)

Code Information:

Lot # HBM1303-4886, Exp 3/6/2016; Lot# HBM1303-4886, Exp 3.6 to 3/21/2016; Lot# HBM1201-02, Exp 1/16/2015; Lot# HBM1203-02, Exp 4/5/2015

Distribution Pattern:

US Distribution GA only.

Voluntary or Mandated:

Voluntary: Firm initiated