Chromophare Surgical Light System recalled for insufficient mounting force
Stryker Communications recalls Chromophare Surgical Light Systems due to insufficient mounting force that could compromise the equipment's stability in surgical environments.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall for a surgical light system with a structural stability defect where no injuries or hospitalizations have been reported. This is a risk-of-harm product where injury has not yet been reported, matching the High severity criterion.
Plain-English summary
Stryker Communications is recalling the Chromophare Surgical Light System, model REF CH00000001, due to insufficient mounting force that compromises the stability of the device during use.
The system was distributed outside the United States in Chile. Affected units can be identified by serial number 03857056 and UDI 07613327296167.
Operating room staff and healthcare facilities should be aware of this safety issue. For information on this recall and available remediation options, contact Stryker Communications directly.
The recalled product
- Product
- Chromophare Surgical Light System , REF CH00000001
- Manufacturer
- Stryker Communications
- Affected units
- 1
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 (1)
- S/N:03857056/ UDI: 07613327296167
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Stryker Communications
See all →- HighStryker surgical light assembly may not support the ceiling cover weight
FDA (Devices) · 2026-04-08
- ModerateSurgical light systems recalled over powder coating stress lines and chipping
FDA (Devices) · 2025-10-01
- 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 · mounting failure
See all →- HighSMV BodyTrack nuclear medicine systems recalled over a potential detector fall
FDA (Food) · 2026-01-21
- HighNuclear medicine systems recalled over inadequate detector support during transport
FDA (Drugs) · 2026-01-21
- HighSMV DSI nuclear medicine systems recalled over a potential detector fall
FDA (Devices) · 2026-01-21
- HighSMV DSX New Line systems recalled over a potential detector fall
FDA (Devices) · 2026-01-21
- HighGE Healthcare Nuclear Medicine Systems Recalled for Potential Detector Fall Risk
FDA (Devices) · 2025-01-22
Similar recalls
- HighStryker surgical light assembly may not support the ceiling cover weight
FDA (Devices) · 2026-04-08
- SevereStryker Recalls Ceiling Mounted Surgical Light Systems Due to Fall Risk
FDA (Devices) · 2020-04-08
- HighStryker Berchtold Chromophare Surgical Light Recall for Missing Parts
FDA (Devices) · 2018-03-07
- SevereStryker Recalls Berchtold Chromophare F300 Exam Lights Due to Mounting Defect
FDA (Devices) · 2017-06-14
- ModerateSurgical light systems recalled over powder coating stress lines and chipping
FDA (Devices) · 2025-10-01
- HighStryker Recalls Berchtold Chromophare Monitor Arms Due to Weld Defects
FDA (Devices) · 2018-03-07