Stryker Corporation recalls Stryker

Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

On June 18, 2025, Stryker issued a "Urgent: Medical Device Recall" Notification to affected consignees. On November 20, 2025, Stryker initiated a recall notification update. 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 affected product. 3. If affected product is found, quarantine and initiate the return process for affected units. 3a. Please complete Business Reply Form or use QR Code on Attachment A to return product. 4. If affected product is NOT found: 4a. Please complete Business Reply Form or use QR Code on Attachment A. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Response is required.

• FDA enforcement recordOfficial FDA database entry for Z-2171-2025
• FDA 510(k) clearance · K954726The device's official FDA premarket clearance record
• FDA device classification · GCXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.6740The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Stryker CorporationSearch 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.