FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline 22F Robinson catheter kits recalled for connector detachment and surface defects

OTHERNationwide distribution

Medline Robinson catheters recalled for connector detachment risk

Medline identified manufacturing defects in certain batches of 22F Robinson sterile catheter kits. Some catheters had rough surface finishes, connectors that detached prematurely, or outer diameters that didn't meet specifications. About 1,000 units were affected worldwide.

  • Check if you have any of the affected lot numbers: 25JMK709, 25FMJ661, 25CMG042, 24IME549, 24GMD004, 24CMF091, 24CME465, or 24BMH490.
  • Do not use affected kits. Contact your supplier or Medline for instructions on return or replacement.
  • If a catheter connector detached during use, contact your healthcare provider.
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
1000 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2492-2026

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