CLASS II ONGOING Device recall · Reported 18 Sep 2019 · FDA Enforcement Report

Berchtold Chromophare F628 Surgical Lights recalled

Stryker Communications is recalling Berchtold Chromophare F628 Surgical Lights, distributed nationwide in the US. The recall was initiated on 22 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial number ranges: 83171-0017818 to 83171-0123938

Quantity recalled3,344 lights

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2540-2019
FDA event ID: 83355
Recalling firm: Stryker Communications, Flower Mound, TX
Classification: Class II
Status: Ongoing
Recall initiated: 22 Mar 2019
FDA classified: 12 Sep 2019
Reported: 18 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

22 Mar 2019	Recall initiated by company
12 Sep 2019	Classified by FDA	+174 days
18 Sep 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The back cover of the light head was insufficiently assembled and could potentially fall off the light.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

The back cover of the light head was insufficiently assembled and could potentially fall off the light.

Which lots are affected?

Serial number ranges: 83171-0017818 to 83171-0123938

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 83355

Reported	Class	Recall	Company	Reason	Where
18 Sep 2019	CLASS II	Berchtold Chromophare F528 Surgical Lights recalled	Stryker Communications	Other	Nationwide

More recalls from Stryker Communications

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Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	Stryker Chromophare Softlit Ring Surgical Light System recalled	Stryker Communications	Device Malfunction	Nationwide
1 Oct 2025Device	CLASS II	Chromophare Surgical Light System recalled by Stryker Communications	Stryker Communications	Other	Nationwide
17 Apr 2024Device	CLASS II	Chromophare Surgical Light System recalled by Stryker Communications	Stryker Communications	Potency & Assay	TX
31 Mar 2021Device	CLASS II	S-Series Equipment Management System recalled by Stryker Communications	Stryker Communications	Other	Nationwide
8 Apr 2020Device	CLASS II	Berchtold Chromophare Ceiling Mounted Surgical Light System recalled	Stryker Communications	Other	Nationwide

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