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-1716-2026
- 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
- 17902 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. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A.
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 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 401934894608
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-1716-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.