Quick Facts at a Glance
- Recall Date
- September 15, 2025
- Hazard Level
- HIGH
- Brand
- Alcon
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Alcon
- Product type
- Ophthalmic Surgical Equipment
- Model numbers
- UDI-DI/REF: 5414660389996/C26992-01, 5414660396666/C23069-05, 5414660396697/C23125-04, 5414660400332/C17655-06, 5414660400356/C17731-06, 5414660401254/C27454-02, 5414660401285/C27450-02, 5414660401292/C27449-02 +13 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 15, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
XXX
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Alcon Research LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
CONSTELLATION Ultravit 10K and HyperVit 20K are ophthalmic surgical systems used in vitreoretinal procedures. They are designed for precise vitreous cutting and fluid management.
Why This Is Dangerous
The recall notice lists a hazard as unknown in the provided materials. No public hazard details are available in the data.
Industry Context
This recall is not clearly described as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and surgical centers must halt use and coordinate with Alcon for remediation; patient safety implications depend on the hazard details.”
Practical Guidance
How to identify if yours is affected
- Review the recall notice for model and UDI numbers.
- Cross-check your inventory against the provided model list.
- Identify all affected devices in your facility and quarantine them.
Where to find product info
Refer to the FDA enforcement page linked in the recall notice and Alcon’s official recall communications for identifiers and next steps.
What timeline to expect
Remediation timelines are determined by the manufacturer; facilities should expect coordination with suppliers. Typical recall remediation for medical
If the manufacturer is unresponsive
- Escalate to FDA recall contacts or your hospital supply chain management.
- Document all communications and deadlines with the manufacturer.
How to prevent similar issues
- Implement recall screening for all ophthalmic surgical equipment before procurement.
- Request recall status updates from suppliers prior to accepting shipments.
- Verify UDI and model numbers before reintroducing equipment into operating rooms.
Documentation advice
Keep copies of recall notices, inventory lists, purchase records, and all correspondence with the manufacturer.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distribution: Worldwide to hospitals and surgical centers
- Hazard: Listed as Unknown in notice
- Model numbers/UDI: See model list in recall data
- Remedy: Stop use and follow manufacturer guidance
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
