FDA-Device2026-04-15Class IPROCESSING DEFECT

Medline NAMIC Angiographic Control Syringe recalled for loose connector risk

OTHERNationwide distributionMedical devices

What this means

Medline's NAMIC Angiographic Control Syringes may have a rotating adapter that can unwind during use, causing the syringe to disconnect from the manifold. This could interrupt fluid delivery during medical procedures. The issue was found through post-market monitoring.

  • Check if you have any of the affected Medline SKU numbers (70083007, 70084007, 70084017, 80083007, 80084007, or 80084017)
  • Check the lot number on the package against the FDA recall list
  • Stop using affected syringes immediately
  • Contact Medline or your healthcare facility for replacement or instructions
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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
192690 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1713-2026

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