STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
FDA Recall Z-2863-2026 · Posted 2026-08-03
Recalling FirmStryker Corporation
Recall StatusOpen, Classified
Product CodeGCX
Date Initiated2026-06-08
Product Quantity41,052 units
Reason for Recall
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Firm Action
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 [email protected] or Stryker Customer Service at 800-624-4422.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.