- 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 # DYNJ63673D, UDI/DI each 10195327304843, UDI/DI case 40195327304844 , Lot Number: 25GLA141
- Units affected
- 240 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-1725-2026
- 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