Stryker Recalls Berchtold Chromophare F300 Exam Lights Due to Mounting Defect
Stryker Communications is recalling 57 Berchtold Chromophare F300 exam lights because a tolerance issue may cause the equipment to fall, posing a risk of serious injury.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect may cause the equipment to fall, resulting in serious injury. Per the rubric, significant injury reports or risks of serious injury in medical devices warrant a Severe (4) classification.
Plain-English summary
Stryker Communications is recalling 57 units of the Berchtold Chromophare F300 Exam Light. These medical lights are used for local illumination of patients' bodies to aid in the diagnosis and treatment of illnesses, injuries, and disabilities. The affected units were distributed in the US and Canada.
The recall is due to a potential tolerance issue with the adapter assembly. This defect may prevent the snap ring from seating correctly, resulting in insufficient mount force. If the mount force is insufficient, the equipment may fall, which could result in serious injury.
Healthcare facilities and consumers should check their serial numbers against the list provided in the official recall notice to determine if their units are affected. No specific instructions for remediation are provided in the source text, but users should contact the manufacturer for guidance.
The recalled product
- Product
- Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated
- Manufacturer
- Stryker Communications
- Affected units
- 57
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)
- Serial Numbers: 7735170-X68377
- 7735170-X68397
- 7735170-X14846
- 7735170-X15688
- 7735170-X14492
- 7735170-X14495
- 7735170-X14497
- 7735170-X14501
- 7735170-X14502
- 7735170-X14504
- 7735170-X14506
- 7735170-X14507
- 7735170-X14508
- 7735170-X14510
- 7735170-X68383
- 7735170-X68384
- 7735170-X68385
- 7735170-X68386
- 7735170-X68393
- 7735170-X68394
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
- 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
Same hazard · falling object
See all →- SevereLithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arms
CPSC · 2026-10-22
- HighMaquet PowerLED 300 Concealed Lighting System Recalled for Detachment Risk
FDA (Devices) · 2026-09-30
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- SevereTerex Digger Derrick Trucks Recalled for Weld Defect
NHTSA · 2026-08-17
Similar recalls
- HighStryker Berchtold Chromophare Surgical Light Recall for Missing Parts
FDA (Devices) · 2018-03-07
- HighStryker Recalls Berchtold Chromophare F628 Surgical Lights Due to Assembly Defect
FDA (Devices) · 2019-09-18
- HighStryker Recalls Berchtold Chromophare F528 Surgical Lights Due to Assembly Defect
FDA (Devices) · 2019-09-18
- SevereStryker Recalls Ceiling Mounted Surgical Light Systems Due to Fall Risk
FDA (Devices) · 2020-04-08
- HighStryker Recalls Berchtold Chromophare Monitor Arms Due to Weld Defects
FDA (Devices) · 2018-03-07
- SevereStryker Recalls Berchtold Chromophare Monitor Carrier Arms Due to Weld Defects
FDA (Devices) · 2019-09-11