CLASS II ONGOING Device recall · Reported 17 Apr 2024 · FDA Enforcement Report
Chromophare Surgical Light System recalled by Stryker Communications
Stryker Communications is recalling Chromophare Surgical Light System. The recall was initiated on 8 Feb 2024 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-1506-2024
- FDA event ID
- 94199
- Recalling firm
- Stryker Communications, Flower Mound, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Feb 2024
- FDA classified
- 9 Apr 2024
- Reported
- 17 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Surgical Instruments
Timeline
| 8 Feb 2024 | Recall initiated by company | |
| 9 Apr 2024 | Classified by FDA | +61 days |
| 17 Apr 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Chromophare Surgical Light System , REF CH00000001
Where it was distributed
US: None OUS: Chili
Questions about this recall
Why was it recalled?
Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
Which lots are affected?
S/N:03857056/ UDI: 07613327296167
Where was it sold?
US: None OUS: Chili
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 | Stryker Chromophare Softlit Ring Surgical Light System recalled | Stryker Communications | Device Malfunction | Nationwide |
| Device | CLASS II | Chromophare Surgical Light System recalled by Stryker Communications | Stryker Communications | Other | Nationwide |
| 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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