The Recall Desk
HighFDA (Devices)·Z-2540-2019·Announced 2019-09-18

Stryker Recalls Berchtold Chromophare F628 Surgical Lights Due to Assembly Defect

Stryker is recalling 3,344 Berchtold Chromophare F628 surgical lights because the back cover of the light head was insufficiently assembled and could fall off.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (falling component) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Stryker Communications is recalling 3,344 Berchtold Chromophare F628 surgical lights. These medical lights are used in hospital treatment rooms to provide localized lighting for detecting and treating disease, injury, and disability. The recall is due to a manufacturing defect where the back cover of the light head was insufficiently assembled, creating a potential risk that the cover could fall off the light.

The affected products were distributed nationwide, including to Puerto Rico, as well as to government and military facilities. Foreign distribution included 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. The affected serial number ranges are 83171-0017818 to 83171-0123938.

Healthcare facilities should stop using the affected surgical lights and contact Stryker Communications for further instructions on the recall process.

The recalled product

Product
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
Manufacturer
Stryker Communications
Category
Medical Device — Surgical Lights
Hazard
Affected units
3,344

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 (1)

  • Serial number ranges: 83171-0017818 to 83171-0123938

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Stryker Communications under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Stryker Communications

See all →

Same hazard · falling object

See all →