FDA Medical devices recall ·
Medline medical convenience kits, containing NAMIC Angiographic Rotating… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1721-2026
- Date
- (initiated February 27, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 594 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. HEAD AND NECK CDS-LF, Medline SKU # CDS780138K; 2. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 3. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 4. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 5. THYROIDECTOMY, Medline SKU # DYNJ910458; 6. LH 3 PORT W/O WASTEBAG, Medline SKU # VASC1081C; 7. LHK, Medline SKU # VASC1510; 8. LHK, Medline SKU # VASC1510.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Medline SKU # CDS780138K, UDI/DI each 10198459205552, UDI/DI case 40198459205553, Lot Number: 25EBR802; Medline SKU # DYNJ36478B, UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 25AMH487; Medline SKU # DYNJ36478B, UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 24JMC622; Medline SKU # DYNJ36478B, UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 24EMD869; Medline SKU # DYNJ910458, UDI/DI each 10195327692469, UDI/DI case 40195327692460, Lot Number: 24LLA039; Medline SKU # VASC1081C, UDI/DI each 10195327054519, UDI/DI case 40195327054510, Lot Number: 25HBU295; Medline SKU # VASC1510, UDI/DI each 10195327686888, UDI/DI case 40195327686889, Lot Number: 24GBO586; Medline SKU # VASC1510, UDI/DI each 10195327686888, UDI/DI case 40195327686889, Lot Number: 24EBG342.
Distribution
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).
States: California Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1721-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.