- Recalling firm
- Mentor Texas, LP.
- Reason for recall
- Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Affected products (lot / model / serial)
- 10081317028335
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Canada, Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Czech Republic.
- Firm location
- Irving, TX, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1682-2026
- Recall initiated
- February 18, 2026
- FDA classification date
- March 27, 2026
- FDA report date
- April 8, 2026
- FDA event ID
- 98482
- Last updated on HTM Vibe
- July 24, 2026