The Recall Desk

FDA (Devices) recall action 83355

Stryker Communications recalled 2 products on 2019-09-18

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-09-18
Critical
0
Units
4,290

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2019-09-18

    Stryker Recalls Berchtold Chromophare F528 Surgical Lights Due to Assembly Defect

    Stryker is recalling 946 Berchtold Chromophare F528 surgical lights because the back cover of the light head was insufficiently assembled and could fall off.

    Product
    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…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··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.

    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…
    Category
    Distribution
    1 state