Z-1318-2018Class II

Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of...

Name: Z-1318-2018 Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of...
Creator: Reliance Medical Products Inc
Published: 2017-12-06
License: https://open.fda.gov/license/

Haag-Streit USA Inc / initiated 2017-12-06 / Terminated / root cause: manufacturing process

FDA source

Reliance Medical Products Inc began a recall of 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... on 2017-12-06. FDA classified it as Class II and gives the reason as "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". 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-1318-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-06
Posted: 2018-04-09
Terminated: 2019-05-02
Recalling firm: Haag-Streit USA 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.
Product code: HKN Refractor, Manual, Non-Powered, Including Phoropter
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Model Number: 525004, 05 and 525006, 07

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1318-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1318-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-09

Product code HKN

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)