FDA-Device2026-04-15Class IPROCESSING DEFECT
Medline medical convenience kits with NAMIC syringes recalled for loose syringe connection
What this means
Medline has recalled medical convenience kits containing NAMIC Angiographic Rotating Adaptor (RA) syringes because the syringe connector may unwind during use. This can cause a loose or complete disconnection between the syringe and the manifold, potentially interrupting medical procedures.
- Stop using the affected Medline medical kits right away
- Check your kits against the lot numbers: 25HBV397, 25CBU222, 26BBC195, 26ABI611, 25LBK402, 25KBH371, 25IBK975, and 25HBQ426
- Contact Medline or your supplier for replacement kits or instructions
- Do not use these syringes on patients
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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).
Affected count
2980 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. NON VASCULAR PACK, Medline SKU # DYNJ68037C; 2. VEIN, Medline SKU # DYNJ89845; 3. VEIN, Medline SKU # DYNJ89845A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1719-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
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- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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