Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K ...
FDA Device Recall #Z-0183-2027 - Class II, August 31, 2026
Recall Summary
| Recall Number | Z-0183-2027 |
| Classification | Class II - Moderate risk |
| Date Initiated | August 31, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 3,551 kits |
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
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 Pattern
US Nationwide distribution in the states of AZ, CA, IN, MD, MO, NJ, OH, and WI.
Lot / 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
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0189-2027 | Class II | Medline convenience kit labeled as: FOOT ANKLE... | Sep 11, 2026 |
| Z-0173-2027 | Class II | Medline surgical convenience kits labeled as: ... | Sep 2, 2026 |
| Z-0168-2027 | Class II | Medline surgical convenience kits labeled as: ... | Sep 2, 2026 |
| Z-0169-2027 | Class II | 1) Product Name AUD OPEN HEART PACK, Medline Ki... | Sep 2, 2026 |
| Z-0171-2027 | Class II | Medline surgical convenience kits labeled as: ... | Sep 2, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.