FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline medical procedure kits recalled for catheter defects

OTHERNationwide distributionMedical devices

What this means

Medline identified that samples of several medical procedure kits did not meet performance standards. Issues included irregular catheter surface finish, premature connector detachment, and catheters with incorrect outer diameter.

  • Check your facility's inventory against the affected lot numbers listed in the FDA recall notice.
  • Do not use affected kits for medical procedures.
  • Contact Medline for replacement kits or return instructions.
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The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Affected count
32438 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH LITHOTOMY MINOR, TRMC- PERI GYN PACK, RICH MINOR LITHOTOMY, etc. (see recall documents for a full list of products)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2506-2026

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