- Recalling firm
- Covidien, LP
- Reason for recall
- The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
- Affected products (lot / model / serial)
- 1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;
- Units affected
- 2448 units
- Distribution pattern
- Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;
- Firm location
- North Haven, CT, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2281-2026
- Recall initiated
- April 15, 2026
- FDA classification date
- June 1, 2026
- FDA report date
- June 10, 2026
- FDA event ID
- 98871
- Last updated on HTM Vibe
- July 23, 2026