HIGHFDA DEVICE

Stryker CHROMOPHARE Softlit Ring Surgical Light System Recalled for Ceiling Cover Weight Risk (2026)

Stryker Communications recalled 6,170 CHROMOPHARE Softlit Ring Surgical Light Systems distributed worldwide after confirming the ceiling cover weight may not be adequately supported. Hospitals should stop using the device immediately and follow recall instructions from the manufacturer. The recall is classified as Class II and is active as of February 23, 2026.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
February 23, 2026
Status
ACTIVE
Severity
8/10

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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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.

  1. Recall announced

    February 23, 2026

  2. Reported by FDA DEVICE

    April 8, 2026

  3. RecallRadar source check

    April 15, 2026

  4. 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

  1. Check if your CHROMOPHARE Softlit Ring Surgical Light System is the recalled REF CH00000001
  2. Review the UDI number: 07613327296167 and look for All Lots
  3. 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

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 Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
CRUSHINGFALL

Product Classification

Product Details

Model Numbers
UDI: 07613327296167
All Lots
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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