Z-1729-2013Class II

Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle...

Name: Z-1729-2013 Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle...
Creator: KooJoo Trading Company
Published: 2013-07-03
License: https://open.fda.gov/license/

KooJoo Trading Company / initiated 2013-07-03 / Terminated / root cause: manufacturing process

FDA source

KooJoo Trading Company began a recall of Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G -... on 2013-07-03. FDA classified it as Class II and gives the reason as "Lancets were not sterilized within the dose range established by sterilization validation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1729-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-03
Posted: 2013-07-13
Terminated: 2015-03-13
Recalling firm: KooJoo Trading Company
Product: 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 code: FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Reason for recall: Lancets were not sterilized within the dose range established by sterilization validation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, KooJoo, sent a "MEDICAL DEVICE VOLUNTARY T RECALL" letter dated July 3, 2013 via first class mail to its customer. The letter described the product, problem and actions to be taken. The customer was instructed to identify and hold all safety lancets you have in inventory that was received before June 2013; notify your retail customers of this product recall and complete and return the attached Customer Reply Form via email to [email protected] and also return form along with any unused/undistributed product for replacement. If you have further questions, please email [email protected] or call 209-403-9191 during 9:00am to 5:00pm M-F PST.
Quantity in commerce: 7, 712, 000 pieces (1928 cartons)
Distribution: US Distribution GA only.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1729-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1729-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-12

Product code FMK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)