RecallRadar

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…

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

AgencyFDA Device
Recall numberZ-0275-2014
ClassificationClass II
Statusterminated
Initiated2013-08-12
Published2013-11-20
Last updated2026-09-13 11:53 UTC
CompanyDeroyal Industries
DistributionUS

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_infoLot 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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