HIGH

Stryker Surgical Light System Recalled Over Chipping Hazard

Stryker Communications recalled 40 surgical light systems on July 15, 2025, due to potential powder coating chipping. This defect increases risks for healthcare providers and patients. Affected products were distributed nationwide, including Texas, Illinois, and New York.

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

Product Details

The recall affects the Chromophare Surgical Light System, REF: CH00000001, and the SLX to Oculan NFC Upgrade Kit, REF: P60034. The recalled units were distributed across the U.S. and are identified by specific serial numbers.

The Hazard

The surgical lights show stress lines on the powder coating. This defect suggests that pieces of the coating may chip off, posing risks during surgical procedures.

Reported Incidents

There have been no reported injuries or incidents related to the chipping hazard at this time. The product has a high hazard classification due to the potential risk it poses.

What to Do

Stop using the surgical light systems immediately. Follow the recall instructions provided by Stryker Communications or consult your healthcare provider for further guidance.

Contact Information

For more information, contact Stryker Communications at 1-800-123-4567 or visit their website at www.stryker.com.

Key Facts

  • Recall date: July 15, 2025
  • 40 units affected
  • Sold nationwide in multiple states
  • High hazard classification
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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
CH00000001
P60034
UDI-DI: 07613327296167
UDI-DI: 07613327651317
7000010116
+19 more
Affected States
ALL
Report Date
October 1, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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