FDA-Device2026-04-15Class IPROCESSING DEFECT
Medline medical procedure kits recalled for syringe adapter disconnection risk
OTHERNationwide distribution
Stop using affected Medline procedure kits
Medline has recalled three medical convenience kits containing NAMIC Angiographic Rotating Adaptor syringes used in surgical procedures. The syringe adapter may unwind during use, causing the syringe to disconnect from the manifold and potentially disrupting the procedure.
- If your facility has Medline SKU #DYNJ63021B, DYNJ64297B, or DYNJ82411, stop using them immediately
- Check lot numbers: 26AMD887, 26AMA970, or 25IMB049
- Contact Medline for instructions on how to return or dispose of affected kits
- Notify your surgical or procedural team that these kits are no longer safe to use
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
20 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. LAPAROSCOPIC HERNIORRHAPHY DSC, Medline SKU # DYNJ63021B; 2. LAP PACK, Medline SKU # DYNJ64297B; 3. MINOR PROCEDURE PACK, Medline SKU # DYNJ82411.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1722-2026More 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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