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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

Chromophare Surgical Light Systems Recalled for Powder Coating Chipping

Agency Publication Date: September 24, 2025
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Summary

Stryker Communications has recalled 40 units of the Chromophare Surgical Light System and SLX to Oculan NFC Upgrade Kits. Stress lines have been found forming on the light's powder coating, indicating that the coating may chip and flake off. If this occurs during a medical procedure, the fragments could fall into a sterile surgical area, posing a risk to patients. Users should stop using the affected equipment and contact the manufacturer to coordinate a repair or replacement.

Risk

The powder coating on the surgical lights can chip and fall into an open surgical site. This contamination increases the risk of infection or other medical complications for patients undergoing surgery.

What You Should Do

  1. This recall affects the Chromophare Surgical Light System (REF CH00000001) and the SLX to Oculan NFC Upgrade Kit (REF P60034).
  2. Identify if your device is affected by checking the model and serial numbers located on the equipment label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled surgical light systems or upgrade kits immediately.
  4. Contact Stryker Communications or your equipment distributor to arrange for a return, replacement, or corrective service.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this safety alert.

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: Chromophare Surgical Light System
Model / REF:
CH00000001
Serial Numbers:
7000010116
7000010117
7000010118
7000010119
7000010120
7000010121
7000010122
7000010123
7000010124
7000010125
7000010141
7000010142
7000010177
7000010178
7000010148
7000010149
7000010157
7000010137
7000010175
7000010176
7000010145
7000010146
7000010147
7000010309
7000010305
7000010307
7000010296
7000010143
7000010150
7000010151
7000010155
UDI:
07613327296167

REF: CH00000001

Product: SLX to Oculan NFC Upgrade Kit
Model / REF:
P60034
Serial Numbers:
1000022
1000023
1000024
1000016
1000017
1000018
1000019
1000020
1000021
UDI:
07613327651317

REF: P60034

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97285
Status: Active
Manufacturer: Stryker Communications
Sold By: Stryker Communications; Medical device distributors
Manufactured In: United States
Units Affected: 40
Distributed To: Texas, Illinois, New York, Utah, Oregon, Arizona, Vermont, Minnesota

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.