Refractor Suspension Arm — Class II medical device recall Z-1318-2018
Terminated recall by Reliance Medical Products Inc, reported 2018-04-18, distributed nationwide. Product has been found with a missing Washer, Retaining Ring, and/or Stop Screw. Recalling firm was notified b
| Recall number | Z-1318-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reliance Medical Products Inc, Mason, OH, United States |
| Recall initiated | 2017-12-06 |
| Classified | 2018-04-09 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2019-05-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CR, JM, JO, KR, NZ, SA, ZA |
| Model numbers | 525004, 525006 |
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1318-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.