FDA-Device2026-04-15Class IPROCESSING DEFECT
Medline medical convenience kits with NAMIC syringes recalled for loose syringe connection
OTHERNationwide distribution
Stop using Medline NAMIC RA syringes immediately
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
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.
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 Industries, LP recalls
- FDA-Device2026-06-03Medline EYE TRAY-LF medical kit recalled for mismatched syringes
- FDA-Device2026-06-03Medline spinal anesthesia and nerve block kits recalled for bupivacaine quality and efficacy concerns
- FDA-Device2026-05-20Medline Namic Preceptor blood pressure manifold recalled for particulate contamination
- FDA-Device2026-05-20Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Medline medical convenience kits with Namic Manifold recalled for particulate contamination
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