DeRoyal — Class II medical device recall Z-0275-2014
Terminated recall by DeRoyal Industries Inc, reported 2013-11-20, distributed nationwide. One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
| Recall number | Z-0275-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2013-08-12 |
| Classified | 2013-11-14 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2014-08-04 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | 32794811 |
| Model numbers | 30-049 |
Product
DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye
Reason for recall
One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
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-0275-2014. 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.