Medline Recalls CONMED AirSeal Access Port Kits Due to Overpressure Alerts
Medline Industries is recalling 3,551 CONMED AirSeal Access Port kits due to potential overpressure alerts and system venting that may delay or end procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to potential erroneous overpressure alerts and system venting that may delay or end procedures. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 3,551 Convenience Kits containing CONMED AirSeal Access Ports (KIT ROBOTICS UROLOGY PROSTATE, DYKMBNDL116G). The recall was initiated by the manufacturer due to a potential for erroneous overpressure alerts and system venting during use.
The affected kits were distributed nationwide in Arizona, California, Indiana, Maryland, Missouri, New Jersey, Ohio, and Wisconsin. The source text does not report any illnesses, injuries, or deaths associated with the use of these devices.
Healthcare facilities should stop using the affected kits and contact Medline Industries for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
- Manufacturer
- Medline Industries, LP
- Affected units
- 3,551
Distribution
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