Stryker Communications recalls Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001
Reason for recall
Surgical light assembly may not adequate support the weight of the ceiling cover.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Stryker CHROMOPHARE Softlit Ring Surgical Light System REF:CH00000001UDI 07613327296167
What the firm is doing
On February 23, 2026 Stryker issued "Urgent: Medical Device Recall" via E-Mail to affected consignees. Stryker ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2.Check your internal inventory to locate the product. 3.Please complete, Business Reply Form, as an acknowledgement of this notice and return the completed form via email to CommunicationsRA1@stryker.com. Response is required. 4. A representative will contact affected accounts to schedule a field service visit to complete an inspection and replacement of the affected component. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. 6. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately.
DistributionShow detailsHide
Worldwide - US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1688-2026
- FDA 510(k) clearance · K120392The device's official FDA premarket clearance record
- FDA device classification · FSYOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4580The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Stryker CommunicationsSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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