Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ90
Summary
The FDA issued a Class II for Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY D 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-0183-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: DYNJ906731K UDI-DI 10195327436346 Lots 24ADB566 24CDB291 24CDB969 24GDB449 24JDA590 24KDB303 25BDB494 25CDA446 25EDB457 25FDA837 25FDB582 25GDA082 DYNJ906731L UDI-DI 10198459403675 Lots 25HDB211 25JDA226 DYNJ906731N UDI-DI 10198459758249 Lots 26EDA043 26FDB001 26FDB487 DYNJG901002A UDI-DI 10195327401481 Lot 24BLA300 DYNJG901002B UDI-DI 10195327677145 Lots 24GLA290 24ILA519 24JLA479 24LLA939 25ALA154 25ELA210 25FLA112 25GLA399 25HLA560 DYNJG901002C UDI-DI 10198459545672 Lots 25JLA619 25KLA897 26ALA207 26BLA625 26CLA984 DYNJG901002D UDI-DI 10198459723742 Lots 26ELA161 26ELA744 26GLA765 26HLA179 DYNJG901004B UDI-DI 10195327677138 Lots 24FLA735 24GLA836 24KLA502 25ALA409 25ALA837 25DLA322 25ELA451 25FLA291 25GLB051 25HLA207 25ILA840 25JLA027 25JLA621 DYNJG901004D UDI-DI 10198459723759 Lots 26DLA382 26ELA743 26FLB123 DYNJ911258A UDI-DI 10198459582097 Lot 26AMF842 DYKMBNDL116D UDI-DI 10195327608866 Lots 24CBF889 24DBA349 DYKMBNDL116F UDI-DI 10198459000706 Lots 24DBS388 24FBC411 24GBK948 24IBV184 24JBB328 DYNJ907827F UDI-DI 10195327345365 Lots 24ABV361 24CBM651 24DBD866 24GBH678 DYNJ50474G UDI-DI 10198459140235 Lots 24KDA630 25ADB023 25BDB826 25CDB231 25DDA066 25HDA254 25JDA520 25LDA008 25LDC029 26DDA900 26FDA459 26FDB573 DYNJ63392C UDI-DI 10195327634643 Lots 24BLA318 24CLA990 24ELA575 24FLA977 24HLA137 24ILA935 DYNJ63392F UDI-DI 10198459315572 Lots 25DLA944 25ELA626 25FLA272 25GLA905 25HLA240 25HLA894 25JLA091 25KLA775 25LLA985 26ALA670 26DLB121 26FLA701
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-0183-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29