Stryker Corporation recalls STRYKER PKG.

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Stryker issued an URGENT: Medical Device Recall notice to its consignees on 7/6/2026 via USPS Certified Mail. The notice explained the issue, potential risks, and requested the following: "Actions needed: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product using Attachment B. 3. If affected product is found a. Quarantine, stop use and initiate the return process for affected units. b. Please complete Business Reply Form or use QR Code on Attachment A. 4. If affected product is NOT found: a. 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." For any additional information or questions please contact Endorecall@stryker.com or Stryker Customer Service at 800-624-4422.

• FDA enforcement recordOfficial FDA database entry for Z-2866-2026
• FDA 510(k) clearance · K963646The device's official FDA premarket clearance record
• FDA device classification · GEIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4400The 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.