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 five medical procedure kit models did not meet quality standards. The kits contained catheters with surface irregularities, connectors that detached prematurely, and diameter measurements outside specifications. These defects could affect proper catheter function during medical procedures.

  • Check the kit SKU and lot number against the recalled list
  • Contact Medline or your facility's procurement team immediately if you have affected kits
  • Do not use recalled kits for patient procedures
  • Return unused kits to Medline or your supplier
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
1248 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VASCULAR MMC, Medline Kit Number/SKU DYNJ905368D; 4) KIT PERIVASCULAR MMC, Medline Kit Number/SKU DYNJ905368B; 5) VP SHUNT PACK, Medline Kit Number/SKU DYNJ46530I.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2488-2026

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