Device recall
Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
- Recall number
- Z-0185-2027
- Event id
- 99888
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medline Industries, LP
- Report date
- Oct 21, 2026
- Posted
- Oct 15, 2026
- Initiated
- Aug 31, 2026
- Center classification date
- Oct 15, 2026
- Product code
- OKV
- Device type
- Obstetrical Kit
- Reason
- 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.
- Root cause
- Process change control
- Quantity
- 3,551 kits
- Code info
- DYKMBNDL116G UDI-DI 10198459156991 Lots 24KBD429 24LBE008 24LBH410 25ABF361 25BBI842 25EBM426 25GBG086 25JBF391 25KBA114 25KBN017 25LBQ601
- Distribution
- US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States