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FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline gynecological procedure kits recalled for catheter defects

Medline
OTHERNationwide distribution

Medline gynecological kits recalled for catheter defects

Medline identified that samples of its medical procedure kits did not meet quality standards. The catheter components had surface irregularities, connectors that detached prematurely, and in some cases incorrect outer diameters.

  • Check your facility's inventory against the affected lot numbers listed in the recall notice.
  • Contact Medline with questions about your specific lot numbers.
  • Follow Medline's guidance on quarantine or replacement of affected kits.
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
44656 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEACONESS PELVIC LAP PACK, FLOYD LAP GYN, GYN LAP PACK, GYN LAPAROSCOPY, GYN MINOR PACK, etc. (see the recall documents for a full list of affected products)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2503-2026

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