Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP...
FDA Device Recall #Z-0182-2027 - Class II, August 31, 2026
Recall Summary
| Recall Number | Z-0182-2027 |
| 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 GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
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
DYNJG901004C UDI-DI 10198459535772 Lots 25LLA307 26BLA900 DYNJ88071 UDI-DI 10198459098512 Lots 24KMD416 24LMG268 25AMH987 25BMA076 25GMK411 DYNJ50474F UDI-DI 10195327559007 Lots 24DDA107 24DDA469 24EDA512 24GDB884 24IDA882
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.