FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline medical procedure kits recalled for catheter defects

OTHERNationwide distribution

Medline procedure kits recalled for catheter defects

Medline identified that samples of several medical procedure kits did not meet quality specifications. Issues included rough catheter surfaces, connectors that detached prematurely, and catheters with incorrect outer diameters. These kits are used in eye and throat surgical procedures.

  • Check if your facility has any of the affected Medline kit SKUs (CDS983775I, CDS983775J, CDS983775K, CDS983775L, CDS983775M, DYNJ84480, DYNJVB1080, or DYNJVB1080A)
  • If you have affected kits, verify the lot number against the FDA recall list
  • Contact Medline or your hospital procurement team for replacement or instructions
Hazard

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

Sold states
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Affected count
2340 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J; 3) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775K; 4) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775L; 5) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775M; 6) TONSIL PACK, Medline Kit Number/SKU DYNJ84480; 7) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080; 8) VITRECTOMY, Medline Kit Number/SKU DYNJVB1080A.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2507-2026

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