Quick Facts at a Glance
- Recall Date
- February 23, 2026
- Hazard Level
- HIGH
- Brand
- Stryker Communications
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- 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
- Stryker Communications
- Product type
- Surgical Light System
- Model numbers
- UDI: 07613327296167, All Lots
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 23, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Surgical light assembly may not adequate support the weight of the ceiling cover.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Stryker Communications or your healthcare provider for instructions
About This Product
The CHROMOPHARE Softlit Ring Surgical Light System is used to illuminate the surgical field during operations. It is designed to provide bright, shadow-free lighting for the operating room.
Why This Is Dangerous
A ceiling cover that is not adequately supported can detach or shift during use, potentially causing injury to patients or staff.
Industry Context
This recall is not currently described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt surgeries temporarily if replacement lighting is not readily available, with potential scheduling and staffing disruptions.
Practical Guidance
How to identify if yours is affected
- Check if your CHROMOPHARE Softlit Ring Surgical Light System is the recalled REF CH00000001
- Review the UDI number: 07613327296167 and look for All Lots
- Consult the hospital’s biomedical engineering department for verification
Where to find product info
FDA recall page and Stryker Communications notices. Use the provided recall URL for official details.
What timeline to expect
Refunds or replacements are typically processed within 4-8 weeks, depending on the provider.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer
- Escalate to the hospital’s procurement or risk management office
- Consult the local safety authority if no progress is made
How to prevent similar issues
- Before purchasing surgical lighting, verify weight ratings, mounting compatibility and service support
- Check for recall history during supplier vetting
- Ask vendors about contingencies for recall events
Documentation advice
Keep the recall notice, correspondence, and photos of the product and installation for records
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Product Details
Model numbers: UDI 07613327296167; All Lots. Sold worldwide. Quantity: 6,170 units. REF CH00000001. No price data available.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model numbers: UDI 07613327296167; All Lots
- Hazard: ceiling cover weight support
- Remedy: stop use and contact manufacturer
- Retailers: Multiple Retailers
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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