Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY D
Summary
The FDA issued a Class II for Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC by Medline Industries, LP. Reason: Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system ventin.
Details
Source
Device Recall
External ID
Z-0184-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M
Lot/Code Info: DYNJ911135A UDI-DI 10198459655623 Lot 26EDA606 DYNJ906731M UDI-DI 10198459567117 Lots 25KDA658 25KDB571 25LDB411 26CDA536
Quantity Affected: 3,551 kits
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-31
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
Medline Industries, LP has 607 FDA actions in our database, including 576 recalls and 31 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 607 FDA actions in our database, including 576 recalls and 31 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0184-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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