FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline laparoscopy procedure kits recalled for catheter defects

OTHERNationwide distribution

Medline laparoscopy kits recalled for catheter defects

Medline identified defects in laparoscopy procedure kits (SKU DYNJ37378A) during an internal review. The catheter connector may detach prematurely, the catheter surface finish may be irregular, or the catheter diameter may not meet specifications.

  • Check your inventory for kit SKU DYNJ37378A (lot number DYNJ37378A).
  • Contact Medline for further instructions on affected units.
  • Do not use kits with the identified lot number until you receive guidance.
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
72 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2485-2026

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