Tray Surgical — Class II medical device recall Z-1934-2013
Terminated recall by Medtronic Xomed, Inc., reported 2013-08-21, distributed nationwide. The firm will recall and replace the identified instrument trays in the field, with trays that have improved l
| Recall number | Z-1934-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Xomed, Inc., Jacksonville, FL, United States |
| Recall initiated | 2013-07-09 |
| Classified | 2013-08-09 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2014-09-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CL, CN, CO, CR, CY, DE, EC, ES, FR, GB, GR, GT, HK, IE, IL, IN, IR, IT, JP, KR, KW, LB, LU, MA, MX, NG, NI, NL, NZ, PT, QA, SA, SE, SG, TH, TR, TW, VE, VN, ZA |
| Quantity | 3,562 trays |
| Reason classes | labeling |
| Model numbers | 3319005, 3717000, 3717001, 3717006, 3717026, 3722301, 3747108, 960-619, 960374, MCLS28, MCLS37, MCO649SC, MCOH0SC, MCOS10SC |
Product
Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.
Reason for recall
The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY"
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-1934-2013. 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.