FDA Medical Device Recalls (openFDA)
Reliance Medical Products Inc: Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a refractor.
- Recall number
- Z-1318-2018
- Recalling firm
- Reliance Medical Products Inc
- Product
- Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a refractor.
- Status
- Terminated
- Initiated
- 2017-12-06
- Posted
- not on file
- Terminated
- 2019-05-02
- Reason
- Product has been found with a missing Washer, Retaining Ring, and/or Stop Screw. Recalling firm was notified by distributor that Refractor Suspension Arm fell on a patient s lower torso along with the arm housing
- Root cause
- Employee error
- Action
- Recalling firm sent letter to customers via certified mail for US customers and via regular mail to foreign customers. Verify product has the presence of the one or more of the three parts: Refractor Suspension Arm missing Screw, Washer and/or Retaining Ring (Snap Ring) that may be missing, and to assure it is functioning properly. For further questions, please call (513) 398-3937
- Quantity
- 933 ( of which 97 has been quarantined)
- Distribution
- Worldwide Distribution - USA(nationwide) Distribution to the states of : NJ, CA, OH, VA, MA, MN, IL , UT, TN, AR, LA, AZ, PA, TX, IA and HI., and to the countries of : Costa Rica, Jamaica, South Africa, New Zealand, South Korea, Dubai, Saudi Arabia and Jordan.
- Lot, serial or model codes
- Model Number: 525004, 05 and 525006, 07
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HKN
- Firm FEI
- 1000136533
- Firm city
- Mason
- Firm state
- OH
- 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