CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report
Stryker Chromophare Softlit Ring Surgical Light System recalled
Stryker Communications is recalling Stryker Chromophare Softlit Ring Surgical Light System, distributed nationwide in the US. The recall was initiated on 23 Feb 2026 and the FDA has classified it as Class II.
Check your package
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-1688-2026
- FDA event ID
- 98514
- Recalling firm
- Stryker Communications, Flower Mound, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Feb 2026
- FDA classified
- 27 Mar 2026
- Reported
- 8 Apr 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 23 Feb 2026 | Recall initiated by company | |
| 27 Mar 2026 | Classified by FDA | +32 days |
| 8 Apr 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Surgical light assembly may not adequate support the weight of the ceiling cover.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
Why was it recalled?
Surgical light assembly may not adequate support the weight of the ceiling cover.
Which lots are affected?
UDI: 07613327296167; All Lots
Where was it sold?
Worldwide - US Nationwide distribution.
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.
More recalls from Stryker Communications
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Chromophare Surgical Light System recalled by Stryker Communications | Stryker Communications | Other | Nationwide |
| Device | CLASS II | Chromophare Surgical Light System recalled by Stryker Communications | Stryker Communications | Potency & Assay | TX |
| Device | CLASS II | S-Series Equipment Management System recalled by Stryker Communications | Stryker Communications | Other | Nationwide |
| Device | CLASS II | Berchtold Chromophare Ceiling Mounted Surgical Light System recalled | Stryker Communications | Other | Nationwide |
| Device | CLASS II | Berchtold Chromophare F528 Surgical Lights recalled | Stryker Communications | Other | Nationwide |
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| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |