Medline Industries, LP
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
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
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
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →