SPHERES 8801071 1/TRAY 12PK — Class II medical device recall Z-1595-2014
Terminated recall by Medtronic Navigation, Inc., reported 2014-11-26, distributed nationwide. Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not suffi
| Recall number | Z-1595-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2014-04-24 |
| Classified | 2014-11-20 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2014-12-29 |
| Distributed | Nationwide (US) |
| Quantity | 26,674 total |
| Reason classes | sterility |
| Lot numbers | 1203122, 1205291, 1206251, 1306081, 1309101 |
Product
SPHERES 8801071 1/TRAY 12PK
Reason for recall
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
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-1595-2014. 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.