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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Stryker CHROMOPHARE Softlit Ring Surgical Light System Recalled for Fall Risk

Agency Publication Date: March 27, 2026
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Summary

Stryker Communications has recalled 6,170 CHROMOPHARE Softlit Ring Surgical Light Systems because the ceiling cover may not be adequately supported by the light assembly. This defect can cause the ceiling cover to detach and fall during use. Affected units were distributed nationwide and worldwide between February 2026 and the recall initiation date. Consumers should stop using the lights and contact the manufacturer to arrange for a correction of the assembly.

Risk

The ceiling cover can fall from the surgical light assembly, potentially striking and injuring patients or medical staff in the operating room during a procedure.

What You Should Do

  1. Identify your device by checking the product label for the name 'Stryker CHROMOPHARE Softlit Ring Surgical Light System' and Reference (REF) number CH00000001.
  2. Check the Unique Device Identifier (UDI) 07613327296167 on the device packaging or documentation; all lots are included in this recall.
  3. Stop using the recalled device immediately to prevent injury from falling components.
  4. Contact Stryker Communications or your equipment distributor to arrange for a return, replacement, or correction of the light assembly support.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or to report any incidents.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Stryker CHROMOPHARE Softlit Ring Surgical Light System
Model / REF:
CH00000001
Lot Numbers:
All Lots
UDI:
07613327296167

Recall #: Z-1688-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98514
Status: Active
Manufacturer: Stryker Communications
Sold By: Stryker Communications; authorized medical device distributors
Manufactured In: United States
Units Affected: 6170 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.