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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmAugust 31, 2026
Date PostedOctober 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0183-2027
Recall Event ID 99888
Product Classification Gynecological laparoscopic kit - Product Code OHD
ProductConvenience 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
Code Information 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
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-633-5463
Manufacturer 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.
FDA Determined
Cause 2		Process change control
ActionThe firm began notifying customers on August 31, 2026. Customers were provided with CONMED's original recall notification, which instructs users to have a replacement AirSeal disposable be available prior to the procedure in order to minimize potential delays. Users should ensure tubing is properly connected between the tube set and access ports prior to initiating insufflation. If the connection cannot be securely tightened and the "overpressure" alert cannot be resolved, users should replace the affected device. Users were also provided with instructions on how to connect the AirSeal tubeset and access ports, which include new figures as an update to the prior Instructions for Use. The corrected Instructions for Use are available electronically at eifu.conmed.com/eifu.
Quantity in Commerce3,551 kits
DistributionUS Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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