Reliance Medical Products Recalls Refractor Suspension Arms Due to Missing Parts
Reliance Medical Products is recalling 933 Refractor Suspension Arms because missing parts caused the device to fall on a patient.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a reported incident where the device fell on a patient's lower torso, meeting the criteria for a Severe rating due to significant injury reports.
Plain-English summary
Reliance Medical Products Inc is recalling 933 units of Refractor Suspension Arms (P/N: 525004, 05 and 525006, 07). The recall was initiated after the firm was notified by a distributor that a Refractor Suspension Arm fell on a patient's lower torso along with the arm housing. The product has been found with a missing Washer, Retaining Ring, and/or Stop Screw.
The affected devices are intended to store and position ophthalmological examination and diagnostic equipment, specifically a refractor. The recall covers units distributed worldwide, including nationwide distribution in the United States to the states of NJ, CA, OH, VA, MA, MN, IL, UT, TN, AR, LA, AZ, PA, TX, IA, and HI, as well as to Costa Rica, Jamaica, South Africa, New Zealand, South Korea, Dubai, Saudi Arabia, and Jordan. Of the 933 units, 97 have been quarantined.
Healthcare facilities and distributors should stop using the affected Refractor Suspension Arms immediately. Users should contact Reliance Medical Products Inc for instructions on how to return the devices or obtain replacements.
The recalled product
- 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…
- Manufacturer
- Reliance Medical Products Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: 525004
- 05 and 525006
- 07
Distribution
Related recalls
Same hazard · falling object
See all →- SevereLithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arms
CPSC · 2026-10-22
- HighMaquet PowerLED 300 Concealed Lighting System Recalled for Detachment Risk
FDA (Devices) · 2026-09-30
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- SevereTerex Digger Derrick Trucks Recalled for Weld Defect
NHTSA · 2026-08-17
Similar recalls
- HighNidek RT-5100 and RT-3100 Refractors Recalled for Potential Injury
FDA (Devices) · 2014-07-02
- HighNidek RT-5100 and RT-3100 Refractors Recalled for Arm Malfunction
FDA (Devices) · 2016-03-30
- HighOssur Recalls Multiple Medical Devices Including Back Support Suspenders
FDA (Devices) · 2016-04-06
- HighAllen Medical Systems Recalls Traction Boots Due to Assembly Defect
FDA (Devices) · 2013-03-27
- ModerateSynthes Flex Arm Recalled for Potential Connection Failure
FDA (Devices) · 2018-05-02
- HighApplied Medical Technology Recalls Self-Retaining Retractor Frames Due to Sterilization Breach
FDA (Devices) · 2016-05-11