FDA-Device2026-04-15Class IPROCESSING DEFECT
Medline medical convenience kits recalled for syringe adaptor disconnection risk
What this means
Medline has recalled specific batches of medical convenience kits used in robotic procedures because the syringe rotating adaptor may unwind during use. This can cause the syringe to loosen or fully disconnect from the manifold, potentially affecting the procedure. No injuries have been reported.
- Check your kit SKU number: DYNJ58475F or DYNJ60803J
- Verify the lot number matches the affected batches listed in the recall
- Stop using affected kits immediately and isolate them
- Contact Medline or your hospital supply department for replacement instructions
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
439 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. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1728-2026More 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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