FDA Medical Device Recalls (openFDA)
Phillips Safety Products: 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.
- Recall number
- Z-2167-2008
- Recalling firm
- Phillips Safety Products
- 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.
- Status
- Terminated
- Initiated
- 2008-06-05
- Posted
- 2008-08-25
- Terminated
- 2008-12-24
- Reason
- Radiation Protective Eyewear does not meet the radiation protection levels stated on the labeling.
- 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
- 845 pairs of eyewear
- Distribution
- Worldwide Distribution --- including USA and countries of Spain, Norway, Great Britain and the Netherlands.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HOY
- Firm FEI
- 3004183518
- Firm city
- Middlesex
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28