FDA Device recall Z-1729-2013
Safety Lancets - Odyssey, Button Activated
- FDA Device
- Class II
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class II recall of Safety Lancets - Odyssey, Button Activated by Koojoo Trading, citing lancets were not sterilized within the dose range established by sterilization validation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1729-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-03 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Koojoo Trading |
| Distribution | GA |
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.
Reason
Lancets were not sterilized within the dose range established by sterilization validation.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1729-2013%22
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