LUNA Chest — Class III medical device recall Z-0469-2015
Terminated recall by Novadaq Technologies, Inc., reported 2014-12-03, distributed nationwide. Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
| Recall number | Z-0469-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novadaq Technologies, Inc., Richmond, British Columbia, Canada |
| Recall initiated | 2014-11-04 |
| Classified | 2014-11-26 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2015-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 828 units |
| Reason classes | labeling, sterility |
| Lot numbers | 13116, 14012, 14017, 14056, 14074, 14103, 14107, D130282, D132172, D132602, D132712, D141002, D162692 |
| Model numbers | LU4006 |
Product
LUNA Chest, Model No. LU4006
Reason for recall
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
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-0469-2015. 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.