- 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 # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26BBI625; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 26ABB718; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25JBJ140; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25HBF702; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25GBC747; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25DBR341; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25CBK686; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 25ABR102; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24IBK765; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24GBS605; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24EBO156; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24BBG055; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 24ABH036; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23LBI829; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23KBN009; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23FBO996; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23FBA259; Medline SKU # 60010508, UDI/DI each 10193489040340, UDI/DI case 40193489040341, Lot Number: 23EBD151; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24IBE239; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24HBR112; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24GBY032; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24BBO470; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 24ABB436; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23LBA225; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23GBK257; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23FBG433; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23FBC618; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23EBX036; Medline SKU # 60100701, UDI/DI each 10193489045246, UDI/DI case 40193489045247, Lot Number: 23DBD220; Medline SKU # 60131209, UDI/DI each 10193489046779, UDI/DI case 40193489046770, Lot Number: 24HBJ211; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24EBQ349; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24CBD613; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 24ABL640; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23KBB857; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23IBC156; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23FBJ161; Medline SKU # 60160075, UDI/DI each 10193489048872, UDI/DI case 40193489048873, Lot Number: 23FBC907; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Number: 26ABD974; Medline SKU # 60161954, UDI/DI each 10193489049091, UDI/DI case 40193489049092, Lot Nu
- Units affected
- 79843 units
- 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-1724-2026
- 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