- 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 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 24BBI341; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23LBP066; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23KBS305; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23JBA062; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23HBR594; Medline SKU 00-HCT055P, UDI/DI each 10193489297393, UDI/DI case 40193489297394, Lot Number 23DBR051; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 24ABO014; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23KBW878; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23HBP761; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23FBW006; Medline SKU DYNJ0376230Q, UDI/DI each 10193489759303, UDI/DI case 40193489759304, Lot Number 23DBF403; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25KMD905; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25IMD215; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25GMI326; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25FMI653; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25EMH566; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25DMI277; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 25AMI608; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24LMH838; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24LMB458; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24JME629; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GME647; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GMB984; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24GMB351; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24EMF938; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24DMH385; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24CMH336; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24CMF956; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24BMA898; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 24AMA108; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23HMH132; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23GMH036; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23GME698; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23FMF802; Medline SKU DYNJ23532C, UDI/DI each 10193489460872, UDI/DI case 40193489460873, Lot Number 23EMJ218; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24JMD976; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24HMA010; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24GMG026; Medline SKU DYNJ40632C, UDI/DI each 10193489461176, UDI/DI case 40193489461177, Lot Number 24GMB098; Medline SKU
- Units affected
- 17902 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-1716-2026
- 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