FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline Pelvic Lap Pack recalled for catheter defects and connector issues

OTHERNationwide distribution

Medline Pelvic Lap Pack recalled for catheter defects

Medline identified quality issues in representative samples of its Pelvic Lap Pack medical procedure kit (SKU DYNJ53820B). Problems include surface irregularities on the catheter, premature detachment of the catheter connector, and instances where the catheter diameter fell outside specification. A total of 20 units were affected.

  • Check your medical supply inventory for kit number DYNJ53820B and lot numbers 25LBI062, 25HBR967, 24JBK618, or 24BBQ860.
  • Contact Medline Industries for instructions on returning or replacing affected units.
  • Do not use kits from the recalled lot numbers until you receive further 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
20 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2502-2026

More Medline Industries, LP recalls

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