FDA-Device2026-04-15Class IPROCESSING DEFECT

Medline medical procedure kits recalled for syringe adapter disconnection risk

OTHERNationwide distributionMedical devices

What this means

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
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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
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-1722-2026

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