CLASS II Device recall · Reported 18 Apr 2018 · FDA Enforcement Report
Refractor Suspension Arm recalled by Reliance Medical Products
Reliance Medical Products is recalling Refractor Suspension Arm (, distributed nationwide in the US. The recall was initiated on 6 Dec 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1318-2018
- FDA event ID
- 79601
- Recalling firm
- Reliance Medical Products, Mason, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Dec 2017
- FDA classified
- 9 Apr 2018
- Reported
- 18 Apr 2018
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Dec 2017 | Recall initiated by company | |
| 9 Apr 2018 | Classified by FDA | +124 days |
| 18 Apr 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArkansasArizonaCaliforniaHawaiiIowaIllinoisLouisianaMassachusettsMinnesotaNew JerseyOhioPennsylvaniaTennesseeTexasUtahVirginia
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Model Number: 525004, 05 and 525006, 07
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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