Phoroptor VRx Digital Refraction System head may become loose or detach
Reichert, Inc. is recalling 122 units of the Phoroptor VRx Digital Refraction System Model 16241 due to an assembly defect that could cause the device head to become loose and potentially detach.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a structural assembly defect with risk of component detachment, qualifying as a risk-of-harm product. The source contains no reports of injuries or illnesses, keeping the score at 3 per the rubric.
Plain-English summary
Reichert, Inc. is recalling the Phoroptor VRx Digital Refraction System, Model 16241. The recall is due to an assembly defect that could cause the device head to become loose and potentially detach.
The recall affects 122 units distributed nationwide in the United States and internationally to Austria, Bolivia, Canada, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Morocco, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, Slovakia, Switzerland, Thailand, United Arab Emirates, and the United Kingdom.
The U.S. Food and Drug Administration is overseeing this Class II recall.
The recalled product
- Product
- Phoroptor VRx Digital Refraction System Model Numbers: 16241
- Manufacturer
- Reichert, Inc.
- Affected units
- 122
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 Numbers: (1) 16241
- UDI-DI: (1) 00812559011716
- Serial Numbers: TBD
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Reichert, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Reichert, Inc.
See all →- HighPhoroptor VRx Digital Refraction System Recalled for Detachable Head
FDA (Devices) · 2025-04-09
- HighPhoroptor VRx Digital Refraction System head detachment hazard recall
FDA (Devices) · 2023-09-06
Same hazard · loose component
See all →- HighRitchey Recalls Carbon Bicycle Forks Due to Fall and Crash Hazard
CPSC · 2026-08-13
- SevereGiraffe infant resuscitation system may deliver wrong oxygen concentration
FDA (Devices) · 2026-06-24
- SevereGiraffe and Panda warmer blender knobs may deliver wrong oxygen concentration
FDA (Devices) · 2026-06-24
- SeverePanda freestanding warmer blender knobs may deliver wrong oxygen concentration
FDA (Devices) · 2026-06-24
- HighVolkswagen Atlas engine covers can come loose and contact hot surfaces
NHTSA · 2025-02-17
Similar recalls
- HighPhoroptor VRx Digital Refraction System head detachment hazard recall
FDA (Devices) · 2023-09-06
- SevereApollo DRF X-ray Systems Recalled Due to Footrest Detachment Hazard
FDA (Devices) · 2017-03-15
- HighRoberts Digital VIPR System Battery Rupture Risk Recall
FDA (Devices) · 2021-12-01
- SevereMedtronic Mazor X Surgical System Positioner Recalled for Detachment Risk
FDA (Devices) · 2020-06-17
- HighRadiographic imaging system tubes may fall due to bolt rupture
FDA (Devices) · 2024-06-05
- SeverePro-Med DORO LUCENT Headrest System Recalled for Malfunction Risk
FDA (Devices) · 2018-09-26