Flower Mound, TX, United States
Stryker Communications recalls
10 recalls recorded since 2018, most recently on 23 February 2026. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls10
Ongoing (FDA)6
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 February 2026
- Reason
- Surgical light assembly may not adequate support the weight of the ceiling cover.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1688-2026
- Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Ongoing Class II Medical devices
- Recall started
- 15 July 2025
- Reason
- Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
- Distribution
- US Nationwide distribution in the states of TX, IL, NY, UT, OR, AZ, VT, NY, IL, MN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2620-2025
- Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Ongoing Class II Medical devices
- Recall started
- 8 February 2024
- Reason
- Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
- Distribution
- US: None OUS: Chili
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1506-2024
- Chromophare Surgical Light System , REF CH00000001
Ongoing Class II Medical devices
- Recall started
- 29 January 2021
- Reason
- The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY. The country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1297-2021
- S-Series Equipment Management System; Model Number(s):0682400550; UDI: 07613327400502 Components that are affected within the S-Series Finished Good Model Number o P38198 - ASM, MFR CONTROLLER, FIXED STANDARD o P38199
Terminated Class II Medical devices
- Recall started
- 11 October 2019
- Terminated
- 18 October 2022
- Reason
- The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients.
- Distribution
- US: Nationwide OUS: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1602-2020
- Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
Terminated Class II Medical devices
- Recall started
- 1 August 2019
- Terminated
- 27 April 2021
- Reason
- The mounts on the monitor may have an insufficient weld.
- Distribution
- Distribution was made to CA, CO, CT, FL, GA, IL, IN, MD, MI, MN, MO, NC, NH, NJ, NY, OH, PA, SC, TN, TX, and WI. There was foreign distribution to Canada and Germany. There was no government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2446-2019
- Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
Ongoing Class II Medical devices
- Recall started
- 22 March 2019
- Reason
- The back cover of the light head was insufficiently assembled and could potentially fall off the light.
- Distribution
- Distribution was nationwide, including to Puerto Rico. There was also government/military distribution. Foreign distribution was made to Argentina, Austria, Australia, Belgium, Bulgaria, Canada, China, Colombia, Denmark, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Kazakhstan, Kor
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2540-2019, Z-2539-2019
- Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating dise
- Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating dise
Ongoing Class II Medical devices
- Recall started
- 13 November 2018
- Reason
- There is a potential the joint in the suspension of the device is insufficiently assembled.
- Distribution
- Distribution was nationwide, including Puerto Rico. There was also government/military distribution. Foreign distribution was made to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, France, India, Japan, Korea, Mexico, Netherlands, Spain and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1388-2019
- EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspens
Terminated Class II Medical devices
- Recall started
- 29 January 2018
- Terminated
- 8 July 2019
- Reason
- The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling.
- Distribution
- Worldwide Distribution - US Nationwide Distribution and in the countries of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0828-2018
- Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting f
Terminated Class II Medical devices
- Recall started
- 26 January 2018
- Terminated
- 19 March 2019
- Reason
- The mounts on the monitor may have an insufficient (missing or incomplete) weld.
- Distribution
- Distribution was made to medical facilities nationwide, including government and military distribution. Foreign distribution was made to Canada, Belgium, China, United Kingdom, UAE, France, Germany, Spain, Japan, Ecuador, and Russia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0692-2018
- Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.