- Recalling firm
- Medline Industries, LP
- Reason for recall
- Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- Affected products (lot / model / serial)
- Medline SKU # DYNJ63021B, UDI/DI each 10193489833775UDI/DI case 40193489833776, Lot Number: 26AMD887; Medline SKU # DYNJ64297B, UDI/DI each 10198459472992UDI/DI case 40198459472993, Lot Number: 26AMA970; Medline SKU # DYNJ82411, UDI/DI each 10195327193232UDI/DI case 40195327193233, Lot Number: 25IMB049.
- Units affected
- 20 kits
- Distribution pattern
- Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).
- Firm location
- Northfield, IL, 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-1722-2026
- Recall initiated
- February 27, 2026
- FDA classification date
- April 7, 2026
- FDA report date
- April 15, 2026
- FDA event ID
- 98598
- Last updated on HTM Vibe
- July 24, 2026