FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline medical procedure kits recalled for catheter defects and performance issues

OTHERNationwide distribution

Medline procedure kits recalled for catheter defects

Medline found that certain medical procedure kits did not meet quality standards during an internal review. The kits contained catheters with surface irregularities, connectors that detached prematurely, and in some cases outer diameters that did not meet specifications.

  • Check your kit number and lot number against the recall list (BIOB686, DYNJ83242, DYNJ83242A, DYNJ83242C, DYNJ67486A, DYNJ14052D, DYNJ14052F, DYNJ14053D, DYNJ14053F, and others)
  • Contact Medline or your healthcare facility for instructions on returning or replacing the affected kits
  • Do not use affected kits for patient care until you confirm your lot number is not on the recall list
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
123030 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see the recall documents for a full list of products)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2497-2026

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