Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS
Summary
The FDA issued a Class II for Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC 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-0181-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: DYNJ911258 UDI-DI 10198459306723 Lots 25DMC798 25EMD961 25FMB704 25FMB704Z 25JMG936 25JMI469 DYKMBNDL116I UDI-DI 10198459644764 Lots 26ABL226 26BBD710 26EBC888 26EBH673 DYNJ910997 UDI-DI 10198459241987 Lots 25DMB772 25GMA914 25GMB737 25GMC286 25GMJ509 25IMB332 25IME774 25KMB190 25KMF850 25LMB486 DYNJ910997A UDI-DI 10198459582103 Lots 25LLA437 26BLA786 26CLB107 26DLA500 26DLB085 26FLA287 26GLA058 26GLA968 26GLB068 DYNJ63392D UDI-DI 10198459164507 Lots 25ALA298 25BLA967 DYNJ908720B UDI-DI 10198459642517 Lots 26EBE658 DYNJ85189 UDI-DI 10195327473754 Lots 24AMA883
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-0181-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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