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FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline medical procedure kits recalled for catheter defects

Medline
OTHERNationwide distribution

Medline procedure kits recalled for catheter defects

Medline Industries identified that certain batches of medical procedure kits used in gynecological surgeries did not meet quality standards. The kits contained catheters with surface irregularities, connectors that could detach prematurely, and sizing issues that could affect proper function during procedures.

  • Check your facility's inventory against the affected lot numbers listed in the FDA recall notice
  • Do not use kits from the recalled lots; contact your Medline representative or the FDA for replacement instructions
  • Review procedures performed with affected kits if your facility used them
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
37324 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C HYSTER PACK, FLWR GYN PACK, FS LAP TUBAL LIGATION, HILLSDALE D&C / HYSTEROSCOPY, LAVH NEW BRAUNFELS,TVH PACK, etc (see recall documents for a full list of affected products)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2505-2026

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