Home/Recalls/FDA-Z-1688-2026
FDA DevicesClass II

Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001

Published: April 8, 2026Recall ID: Z-1688-2026Category: devicesCountry: US

Reason for Recall / Hazard

Surgical light assembly may not adequate support the weight of the ceiling cover.

Product Description & Identification

Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001

Affected Products

Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001

Additional Source Details

FieldValue
CityFlower Mound
StateTX
Event id98514
Address 1571 Silveron Blvd
Code infoUDI: 07613327296167; All Lots
Postal code75028
Report date20260408
Product typeDevices
Product quantity6170 units
Reason for recallSurgical light assembly may not adequate support the weight of the ceiling cover.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260223
Center classification date20260327

Overview

  • Recalling FirmStryker Communications
  • StatusOngoing
  • Risk LevelClass II
  • DistributionWorldwide - US Nationwide distribution.
Official Agency Alert