RecallRadar

FDA Device recall Z-2489-2026

MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302

On 2026-06-24 the FDA classified a Class II recall of MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302 by Medline Industries, citing during an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfa….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2489-2026
ClassificationClass II
Statusongoing
Initiated2026-05-04
Published2026-06-24
Last updated2026-09-13 11:58 UTC
CompanyMedline Industries
DistributionUS

Product

MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU DYNJ68302

Reason

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.

Identifiers

code_info
UDI/DI 10193489820478 (each), 40193489820479 (case), Lot Numbers: 24CBL413, 24ABX694, 23JBY172, 23IBI716, 23DBG873, 23…UDI/DI 10193489820478 (each), 40193489820479 (case), Lot Numbers: 24CBL413, 24ABX694, 23JBY172, 23IBI716, 23DBG873, 23BBR326, 23ABH376, 22KBS634, 22JBS743, 22FBT429, 22BBZ842, 22BBK836, 21BBG579, 21ABO658.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2489-2026%22

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