FDA-Device2026-10-21Class IIPROCESSING DEFECT
Medline robotic surgery kits recalled for erroneous overpressure alerts in CONMED ports
What this means
Medline Industries convenience kits used in robotic urology and chest surgery contain CONMED AirSeal Access Ports that may trigger false overpressure alerts and system venting during procedures. This could cause delays or unintended procedure interruptions.
- Contact Medline Industries or your hospital supply department if your facility uses affected kits
- Check lot numbers against the recalled batches (25DMC798, 25EMD961, 25FMB704, and others listed by kit model)
- Do not use affected kits; return to distributor per Medline instructions
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 HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBOTIC CHEST DYNJ910997 DYNJ910997A RR-DAVINCI PROSTATE ACCESSORY DYNJ63392D UROLOGY LAPAROSCOPIC - 51638 DYNJ908720B UROLOGY ROBOT ADD ON PACK DYNJ85189
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0181-2027Also reported as
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