FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline Bilateral Micro Vasectomy Reversal Kit recalled for catheter defects

OTHERNationwide distributionMedical devices

What this means

Medline identified quality issues in certain batches of its Bilateral Micro Vasectomy Reversal Kit (SKU DYNJ68302). Problems include surface irregularities on catheters, premature detachment of catheter connectors, and diameter inconsistencies. No injuries have been reported.

  • Check if you have one of the affected lot numbers (24CBL413, 24ABX694, 23JBY172, 23IBI716, 23DBG873, 23BBR326, 23ABH376, 22KBS634, 22JBS743, 22FBT429, 22BBZ842, 22BBK836, 21BBG579, 21ABO658).
  • If you have an affected kit, contact Medline for guidance on your specific situation.
  • Do not use the kit if you have confirmed it matches an affected lot number.
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The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Affected count
588 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2489-2026

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