Device recall
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M
- Recall number
- Z-0184-2027
- 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
- OJF
- Device type
- Hysterectomy 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
- DYNJ911135A UDI-DI 10198459655623 Lot 26EDA606 DYNJ906731M UDI-DI 10198459567117 Lots 25KDA658 25KDB571 25LDB411 26CDA536
- 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