Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMB...

FDA Device Recall #Z-0185-2027 - Class II, August 31, 2026

Recall Summary

Recall Number Z-0185-2027
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 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G

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

DYKMBNDL116G UDI-DI 10198459156991 Lots 24KBD429 24LBE008 24LBH410 25ABF361 25BBI842 25EBM426 25GBG086 25JBF391 25KBA114 25KBN017 25LBQ601

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.