FDA recall, , Moderate risk
Stryker CHROMOPHARE Softlit Ring Surgical Light System
The surgical light system may not adequately support the weight of the ceiling cover.
Summary by Recall Canary from the FDA notice
What happened
Stryker Communications of Flower Mound, Texas, recalled the Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 because the surgical light assembly may not adequately support the weight of the ceiling cover. The company began the recall on February 23, 2026, and the FDA added it to its Enforcement Report on March 27, 2026. The recall involves 6170 units distributed nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
- UDI-DI
- 07613327296167
- Lot code
- All Lots
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution.
- Company
- Stryker CommunicationsFlower Mound, Texas
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98514
- Recall number
- Z-1688-2026
- Quantity recalled
- 6170 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
