Recall Z-2864-2026
Stryker Corporation · initiated June 8, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
Codes / lots: GTIN 07613327061475, Batch Number: 24284FG2, 24289FG2, 24313FG2, 24322FG2, 24338FG2, 24344FG2, 24351FG2, 25009FG2, 25036FG2, 25062FG2, 25091FG2, 25129FG2, 25161FG2.
Reason for recall
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2864-2026
- Initiated
- June 8, 2026
- Posted by FDA
- August 3, 2026
- Product code
- GCX – Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- Quantity
- 2,739 of units
- Distribution
- 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.
- Recalling firm
- Stryker Corporation, San Jose, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2862-2026 Class II | STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | 06/08/2026Open, Classified |
| Z-2863-2026 Class II | STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | 06/08/2026Open, Classified |
| Z-2865-2026 Class II | STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | 06/08/2026Open, Classified |
| Z-2866-2026 Class II | STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | 06/08/2026Open, Classified |