Surgical light systems recalled over powder coating stress lines and chipping
Chromophare surgical light systems and an associated upgrade kit are being recalled because stress lines in the powder coating indicate that the coating can chip.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a cosmetic-surface defect with no stated hazard or reported harm, which falls under the minor-defect rather than risk-of-harm criterion.
Plain-English summary
Chromophare Surgical Light Systems (REF CH00000001) and the SLX to Oculan NFC Upgrade Kit (REF P60034) are being recalled after stress lines were found forming on the powder coating, which indicates that powder coating chipping can occur.
Forty units are covered. The affected products carry UDI-DIs 07613327296167 and 07613327651317 and were distributed in Texas, Illinois, New York, Utah, Oregon, Arizona, Vermont and Minnesota. The FDA has classified the action as Class II.
The enforcement record describes the coating condition and does not state any injury or clinical consequence. Affected facilities should follow the manufacturer's instructions for inspection or correction of the identified units.
The recalled product
- Product
- Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
- Manufacturer
- Stryker Communications
- Affected units
- 40
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 (20)
- 7000010117
- 7000010118
- 7000010119
- 7000010120
- 7000010121
- 7000010122
- 7000010123
- 7000010124
- 7000010125
- 7000010141
- 7000010142
- 7000010177
- 7000010178
- 7000010148
- 7000010149
- 7000010157
- 7000010137
- 7000010175
- 7000010176
- 7000010145
Distribution
Related recalls
Same manufacturer · Stryker Communications
See all →- HighStryker surgical light assembly may not support the ceiling cover weight
FDA (Devices) · 2026-04-08
- 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 · coating defect
See all →- ModerateBoston Scientific Recalls Defective Direxion Torqueable Microcatheters
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Defective Direxion Torqueable Microcatheters
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters for Coating Defects
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Defective Direxion Torqueable Microcatheters
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Defective Direxion Torqueable Microcatheters
FDA (Devices) · 2026-10-28
Similar recalls
- HighChromophare Surgical Light System recalled for insufficient mounting force
FDA (Devices) · 2024-04-17
- 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
- ModerateHarmonyAIR A-Series surgical light heads may show paint delamination
FDA (Devices) · 2026-06-24
- HighStryker Berchtold Chromophare Surgical Light Recall for Missing Parts
FDA (Devices) · 2018-03-07
- HighMedical Device Illumination Pack Recalled Due to Burn and Occlusion Risks
FDA (Devices) · 2021-06-16