Z-2167-2008

Radiation Protective Eyewear (only involving multifocals. FTC 28 Progress X-Ray Protective Eyewear Protective...

Name: Z-2167-2008 Radiation Protective Eyewear (only involving multifocals. FTC 28 Progress X-Ray Protective Eyewear Protective...
Creator: Phillips Safety Products
Published: 2008-06-05
License: https://open.fda.gov/license/

Phillips Safety Products, Inc. / initiated 2008-06-05 / Terminated / root cause: manufacturing process

FDA source

Phillips Safety Products began a recall of Radiation Protective Eyewear (only involving multifocals. FTC 28 Progress X-Ray Protective Eyewear Protective Eyewear is not sent with any package inserts or... on 2008-06-05. The reason FDA records is "Radiation Protective Eyewear does not meet the radiation protection levels stated on the labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2167-2008
Status: Terminated
Initiated: 2008-06-05
Posted: 2008-08-25
Terminated: 2008-12-24
Recalling firm: Phillips Safety Products, Inc.
Product: Radiation Protective Eyewear (only involving multifocals. FTC 28 Progress X-Ray Protective Eyewear Protective Eyewear is not sent with any package inserts or labeling. It is sent is plain envelope, bag of box.
Product code: HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Reason for recall: Radiation Protective Eyewear does not meet the radiation protection levels stated on the labeling.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were all notified by phone, followed by an Urgent Recall letter dated June 3, 2008. The letter asked that customers examine their stock immediately to determine if they had any of these radiation protective bifocals on hand, discontinue use or distribution of the lot, and set the products aside for further instructions. Also, if customers distributed these items, they needed to contact their accounts and advise them of the recall and have them return their outstanding recall stock to them. The firm will send replacement products in the weeks to follow.
Quantity in commerce: 845 pairs of eyewear
Distribution: Worldwide Distribution --- including USA and countries of Spain, Norway, Great Britain and the Netherlands.
Product codes and lots: ALL radiation protective bifocals, both progressive and FT28 - product numbers: PX-PROG, PX-FT28, FB-103-RXB, FB-500-RXB, FB-100-SRXB, FB-100-BRXB, FB-100-CRXB, FB-108-SRXB, FB-108-BRXB, RGS-97RX-BI, SFFT X-RAY, RGS-53-BI, LT-53-RXP, RG-500-SRG1.5, RG-500-SRG2.0.

Product code HOY

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)