Safety Lancets — Class II medical device recall Z-1729-2013
Terminated recall by KooJoo Trading Company, reported 2013-07-24. Lancets were not sterilized within the dose range established by sterilization validation.
| Recall number | Z-1729-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KooJoo Trading Company, Gimpo City, Gyeongki-Do, N/A, Korea, Republic Of (South) |
| Recall initiated | 2013-07-03 |
| Classified | 2013-07-12 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2015-03-13 |
| Lot numbers | 3.6, HBM1201-02, HBM1203-02, HBM1303-4886 |
| Expiration dates | 2015-01-16, 2015-04-05, 2016-03-06 |
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 for recall
Lancets were not sterilized within the dose range established by sterilization validation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1729-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.