- Recalling firm
- Paragon 28, Inc.
- Reason for recall
- Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
- Affected products (lot / model / serial)
- UDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225; UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225; UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725; UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925; UDI (01)00889795061577(17)301118(10)501275832225, Lot Number 501275832225.
- Units affected
- 514 units
- Distribution pattern
- US nationwide, Australia, Canada, The Netherlands, and New Zealand
- Firm location
- Englewood, CO, 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-2758-2026
- Recall initiated
- June 17, 2026
- FDA classification date
- July 17, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 99276
- Last updated on HTM Vibe
- August 4, 2026