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Medline Industries, LP: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follo

Medical DevicesSource: FDA (device) · Date: 2026-04-15

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J.
Reason / hazard
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.
Classification
Class I
Status
Ongoing
Distribution / sold at
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).
Recall initiated
2026-02-27
Code info
Medline SKU # DYNJ58475F, UDI/DI each 10198459572388, UDI/DI case 40198459572389, Lot Number: 25LMK173; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 26BMA268; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 26AMH928; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25EMD876; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25EMA519; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25DMA846; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25BMH004; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 25BMA218; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24KMI208; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24KMC007; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24JMD850; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24IMI939; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24EDB694; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24DDB793; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24CDB207; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 24BDB439; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 23GDB756; Medline SKU # DYNJ60803J, UDI/DI each 10195327138820, UDI/DI case 40195327138821, Lot Number: 23GDA532.
Product quantity
439 kits
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
98598
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