Z-1505-2012

DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield are sold in...

Name: Z-1505-2012 DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield are sold in...
Creator: O'Ryan Industries Inc
Published: 2012-04-23
License: https://open.fda.gov/license/

O'Ryan Industries Inc / initiated 2012-04-23 / Terminated

FDA source

O'Ryan Industries Inc began a recall of DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield are sold in different sizes from 6 mm, 8 mm, 9 mm, 11 mm and... on 2012-04-23. The reason FDA records is "Disposa-Shield Disposable Curing Shield is recalled due to lacking 510K, PMA or IDE, and inadequate quality system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1505-2012
Status: Terminated
Initiated: 2012-04-23
Posted: 2012-05-09
Terminated: 2012-08-10
Recalling firm: O'Ryan Industries Inc
Product: DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield are sold in different sizes from 6 mm, 8 mm, 9 mm, 11 mm and 13 mm. The devices are Intended to be place over the tip of a dental curing light wand to protect the doctor's and patient's vision from exposure to high intensity light; soften contact of curing light against the teeth, and keep light guide cleaner, therefore maintaining good levels of light intensity for proper and fast curing The label of the O'Ryan Disposa-Shield listed the following: -Protect Doctor's And Patient's Vision From Exposure To High Intensity Light. -Soften Contact Of Light Guide Against Teeth. -Keep Light Guide Cleaner, Therefore, Maintaining Good Levels Of Light Intensity For Proper And Faster Curing. There are 25 devices per clear plastic bag when distributed in bulk and two devices per clear plastic zip lock type bag when distributed with curing lights. The "Sterilize Before Use" label is placed on a clear plastic bag containing 25 pieces of Disposa-Shield units distributed with all shipment of bulk Disposa-Shield. The "Sterilize Before Use" label is NOT placed on plastic zip lock type bag when distributed with two Disposa-Shield with curing lights. The product is labeled in parts: "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***STERILIZE BEFORE USE***O'RYAN INDUSTRIES***INSTRUCTIONS FOR INSTALLING DISPOSA-SHIELD***1. Remove and dispose of old DISPOSA-SHIELD***2. Sterilize wand tip***3. Simply stretch new DISPOSA-SHIELD over tip of wand***800-426-4311 or (360) 892-0447***(360) 892-6742 Fax***[email protected]***'. The private label is labeled in parts: "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***ALMORE INTERNATIONAL , INC***STERILIZE BEFORE USE***".
Product code: EBZ Activator, Ultraviolet, For Polymerization
Reason for recall: Disposa-Shield Disposable Curing Shield is recalled due to lacking 510K, PMA or IDE, and inadequate quality system.
FDA root cause: No Marketing Application
Action: The firm, O'Ryan Industries Inc., began to contact consignees by telephone and sent email on April 25, 2012. O'Ryan sent a recall notification letter dated May 7, 2012 to their customers through the Purchasing Agents and Order Department Personnel. The letter described the product, problem, and actions to be taken by the customers. Customers were advised to return the Disposa-Shield back to O'Ryan Industries. Customers can call O'Ryan Industries at 800-426-4311 or fax to 360-892-6742.
Quantity in commerce: 11,376 units
Distribution: Nationwide distribution: USA including states of NC, MN, OR and WI.
Product codes and lots: No serial numbers, no codes, and no expiration dates.

Product code EBZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)