Stryker Berchtold Chromophare F6:28 Surgical Lights Recall - Back Cover May Detach
Stryker recalls Berchtold Chromophare F628 surgical lights with serial numbers 83171-0017818 to 83171-0123938 due to risk of back cover detachment during use in hospitals.
Use caution until it’s fixed
The back cover of the light head was insufficiently assembled and could potentially fall off the light.
Contact the company
What happened, in plain English
Stryker is recalling Berchtold Chromophare F628 surgical lights that could have their back cover detach while in use. This poses a risk of the cover falling off and potentially causing injury during medical procedures. Read more at govinfonow.com/recall/68563-stryker-berchtold-chromophare-f6-28-surgical-lights-recall-back-cover.
Source Summary by GovInfoNow · govinfonow.com/recall/68563-stryker-berchtold-chromophare-f6-28-surgical-lights-recall-back-cover · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2540-2019
Cite this page
“Stryker Berchtold Chromophare F6:28 Surgical Lights Recall - Back Cover May Detach.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68563-stryker-berchtold-chromophare-f6-28-surgical-lights-recall-back-cover. Based on FDA recall #Z-2540-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2540-2019%22&limit=1).
Why it’s dangerous
The back cover of the light head is not securely assembled and could fall off during use. If the cover detaches, it may cause injury to medical staff or interfere with the lighting during procedures.
Who’s affected
Hospital staff and medical professionals who use these surgical lights in treatment rooms. The risk is highest for those handling the lights during procedures where the cover might detach.
How to tell if you have this one
Check the serial number on the light head. The affected units have serial numbers from 83171-0017818 to 83171-0123938. These lights are used in hospital treatment rooms for medical procedures.
- Brand
Stryker Communications- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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, Korea, Kuwait, Lithuania, Mexico, Netherlands, Philippines, Poland, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2539-2019 | 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 disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.; Serial number ranges: 83180-69712678 to 83180-88970377; | 946 lights |
| Z-2540-2019 | 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 disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.; Serial number ranges: 83171-0017818 to 83171-0123938 | 3,344 lights |
What to do — step by step
Check Serial Number
Look for the serial number on the light head to confirm if it falls within the range 83171-0017818 to 83171-0123938.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are these lights safe to use?
These lights are safe to use in hospitals as long as the back cover remains securely attached. However, the recall indicates a risk of detachment, so they should be checked for proper assembly.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2540-2019 (March 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2540-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.