This is part of a larger recall. The most authoritative record is FDA-Device / Z-0181-2027.

FDA-Device2026-10-21Class IIPROCESSING DEFECT

Medline Convenience Kits with CONMED AirSeal Access Ports recalled for overpressure alert and venting risk

OTHERNationwide distributionMedical devices

What this means

Medline Industries distributed convenience kits containing CONMED AirSeal Access Ports that may produce false overpressure alerts or vent system pressure during robotic surgical procedures. This could cause unexpected delays or premature procedure termination.

  • Check if your facility received affected kits using the lot numbers and UDI codes listed in the FDA notice
  • Do not use affected kits for procedures until replacement units are obtained
  • Contact your Medline or CONMED representative for replacement kits and detailed product lot information
  • Report any incidents or device malfunctions to the FDA MedWatch program
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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 CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901002A DYNJG901002B DYNJG901002C DYNJG901002D GENERAL DAVINCI DYNJG901004B DYNJG901004D HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258A KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116D DYKMBNDL116F ROBOTIC GYN DYNJ907827F ROBOTIC PACK DYNJ50474G RR-DAVINCI PROSTATE ACCESSORY DYNJ63392C DYNJ63392F

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0183-2027

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