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's laparoscopic convenience kits contain CONMED AirSeal Access Ports that may send false overpressure alerts or vent unexpectedly during surgery. This can delay or stop procedures. About 3,551 kits across multiple product lines are affected.

  • Check if your facility has affected kits by matching lot numbers to the FDA notice.
  • Stop using any kits with matching lot numbers immediately.
  • Contact Medline or CONMED for instructions on replacement or return.
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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 ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638 DYNJ908720A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0180-2027

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