Quick Facts at a Glance
- Recall Date
- July 15, 2025
- Hazard Level
- HIGH
- Brand
- Stryker Communications
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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 Lighting System
- Model numbers
- CH00000001, P60034, UDI-DI: 07613327296167, UDI-DI: 07613327651317, 7000010116, 7000010117, 7000010118, 7000010119 +16 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 15, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
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. Notification method: Letter
About This Product
Surgical lighting systems are used in operating rooms to illuminate surgical areas. These include modular light systems and upgrade kits.
Why This Is Dangerous
Powder coating chipping can create surface debris and potential contamination issues near sterile fields.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided data.
Real-World Impact
Immediate halt in use may cause scheduling challenges but reduces contamination risks and potential device failure during procedures.
Practical Guidance
How to identify if yours is affected
- Check model numbers CH00000001 and P60034
- Cross-check with FDA recall page Z-2620-2025
Where to find product info
FDA recall page and the enforcement report linked in the data
What timeline to expect
Refund or replacement timelines not specified; expect manufacturer instructions via mailed notification
If the manufacturer is unresponsive
- Document all attempts to contact manufacturer
- Consult healthcare facility's risk management
- File complaints with CPSC or FDA if needed
How to prevent similar issues
- Verify coatings and material finishes during procurement
- Require validated coatings in medical devices
- Maintain updated recall notifications for all surgical equipment
- Regularly review FDA recall databases
Documentation advice
Keep copies of notification letters, model numbers, UDIs, and any correspondence with the manufacturer
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Product Details
Model numbers: CH00000001, P60034. UDI-DI: 07613327296167 and 07613327651317. Sold nationwide in the United States. No price data provided.
Reported Incidents
No specific injuries or incidents are detailed in the provided recall notice.
Key Facts
- Class II recall
- Hazard level HIGH
- Distribute in TX, IL, NY, UT, OR, AZ, VT, MN
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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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