Recall Z-0185-2027 ยท OKV Obstetrical Kit
Medline Industries, LP
Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
| Date | Oct 15, 2026 (initiated Aug 31, 2026) |
| Status | Open, Classified |
| 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 |
| Action | The firm began notifying customers on August 31, 2026. Customers were provided with CONMED's original recall notification, which instructs users to have a replacement AirSeal disposable be available prior to the procedure in order to minimize potential delays. Users should ensure tubing is properly connected between the tube set and access ports prior to initiating insufflation. If the connection cannot be securely tightened and the "overpressure" alert cannot be resolved, users should replace the affected device. Users were also provided with instructions on how to connect the AirSeal tu |
| Quantity | 3,551 kits |
| Distribution | US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.