FDA-Device2026-04-15Class IPROCESSING DEFECT
Medline medical convenience kits recalled for syringe adaptor disconnection risk
What this means
Medline has recalled certain medical convenience kits (SKU # DYNJ80513B) because the syringe rotating adaptor can unwind during use. This may cause the syringe to become loose or fully disconnect from the manifold, potentially affecting medical procedures.
- Check if you have the affected kit: Medline SKU # DYNJ80513B with lot numbers 26ABH752, 25LBL571, 25KBO421, 25IBF501, 25HBL993, or 25FBU283
- Stop using the kit immediately
- Contact Medline Industries for instructions on return or replacement
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
762 units
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: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1720-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- 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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