FDA Device recall Z-0275-2014
DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN…
- FDA Device
- Class II
- terminated
- Published 2013-11-20
On 2013-11-20 the FDA classified a Class II recall of DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN… by Deroyal Industries, citing one lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0275-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-12 |
| Published | 2013-11-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Deroyal Industries |
| Distribution | US |
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
One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
Identifiers
| code_info | Lot Number 32794811 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0275-2014%22
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