- Recalling firm
- Stryker Corporation
- Reason for recall
- There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Affected products (lot / model / serial)
- GTIN 07613327061475, Batch Number: 24284FG2, 24289FG2, 24313FG2, 24322FG2, 24338FG2, 24344FG2, 24351FG2, 25009FG2, 25036FG2, 25062FG2, 25091FG2, 25129FG2, 25161FG2.
- Units affected
- 2,739 of units
- 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.
- Firm location
- San Jose, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2864-2026
- Recall initiated
- June 8, 2026
- FDA classification date
- August 3, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99340
- Last updated on HTM Vibe
- August 18, 2026