Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc...

FDA Device Recall #Z-2783-2026 - Class II, June 8, 2026

Recall Summary

Recall Number Z-2783-2026
Classification Class II - Moderate risk
Date Initiated June 8, 2026
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medline Industries, LP
Location Northfield, IL
Product Type Devices
Quantity 980 kits

Product Description

Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. PROSTATE ROBOTIC DYNJ901822B

Reason for Recall

Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.

Distribution Pattern

US Nationwide distribution in the states of CA, FL, MD. PA, and TX.

Lot / Code Information

DYNJ901822B UDI-DI 10195327319182 Lots 25KBA955 26CBL889

Other Recalls from Medline Industries, LP

Recall # Classification Product Date
Z-2790-2026 Class II Medline medical convenience kits labeled as: ... Jun 11, 2026
Z-2788-2026 Class II Medline medical convenience kits labeled as: ... Jun 11, 2026
Z-2791-2026 Class II Medline medical convenience kits labeled as: ... Jun 11, 2026
Z-2789-2026 Class II Medline medical convenience kits labeled as: ... Jun 11, 2026
Z-2737-2026 Class II Medline Kits containing Zimmer Biomet mixing bo... Jun 10, 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.