FDA-Device2026-10-21Class IIPROCESSING DEFECT
Medline Convenience Kits with CONMED AirSeal Access Ports recalled for erroneous pressure alerts
What this means
Medline Industries distributed convenience kits containing CONMED AirSeal Access Ports that may trigger false overpressure alerts during robotic urological procedures. When these erroneous alerts occur, the system may vent and interrupt or end the procedure.
- If you use or stock affected kits (lot numbers 24KBD429, 24LBE008, 24KBH410, 25ABF361, 25BBI842, 25EBM426, 25GBG086, 25JBF391, 25KBA114, 25KBN017, 25LBQ601), contact Medline for instructions
- Do not use affected kits until you receive guidance from Medline
The agency's original wording
Hazard
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.
Affected count
3,551 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0185-2027More Medline recalls
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