Stryker surgical light assembly may not support the ceiling cover weight
Stryker is recalling the CHROMOPHARE Softlit Ring Surgical Light System because the light assembly may not adequately support the weight of the ceiling cover.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: an overhead assembly that may not support the ceiling cover is a fall hazard in an operating room, and no injuries are stated.
Plain-English summary
Stryker is recalling the CHROMOPHARE Softlit Ring Surgical Light System, REF CH00000001. About 6,170 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The surgical light assembly may not adequately support the weight of the ceiling cover.
All lots are affected. The device carries UDI 07613327296167.
Facilities can identify affected systems by the REF and UDI above, and may contact Stryker for further information.
The recalled product
- Product
- Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
- Manufacturer
- Stryker Communications
- Affected units
- 6,170
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 07613327296167
- All Lots
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Stryker Communications
See all →- ModerateSurgical light systems recalled over powder coating stress lines and chipping
FDA (Devices) · 2025-10-01
- HighChromophare Surgical Light System recalled for insufficient mounting force
FDA (Devices) · 2024-04-17
- HighStryker S-Series Equipment Management System Recall for Brake Disengagement Risk
FDA (Devices) · 2021-03-31
- SevereStryker Recalls Ceiling Mounted Surgical Light Systems Due to Fall Risk
FDA (Devices) · 2020-04-08
- HighStryker Recalls Berchtold Chromophare F628 Surgical Lights Due to Assembly Defect
FDA (Devices) · 2019-09-18
Same hazard · structural failure
See all →- Severe
- SevereMondraker Recalls Mountain Bicycles with ONOFF S9 Carbon Handlebars
CPSC · 2026-09-03
- SevereT.A. Pelsue Recalls 2024-2025 Trailers Due to Axle Bracket Defect
NHTSA · 2026-08-21
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05