Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS ...
FDA Device Recall #Z-2431-2026 - Class II, April 27, 2026
Recall Summary
| Recall Number | Z-2431-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | April 27, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 49,654 kits total |
Product Description
Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYNJ910084C GYN LAPAROSCOPY CDS CDS982371I GYN LAPAROSCOPY CDS #34-RF CDS920099S GYN LAPAROSCOPY PACK DYNJT3887 DYNJT6876 GYN ROBOTIC CDS CDS984228K GYN ROBOTICS DYNJ911843 KIT LABOR DELIVERY TUBAL LIGAT DYKMBNDL165C ROBOTIC LAP CHOLE CDS CDS985442J ROBOTIC PACK DYNJ84725B DYNJ910594B ROBOTIC SURGERY PACK DYNJ53711B ROBOTICS PACK DYNJ83622C UOFL GYN LAPAROSCOPY DYNJ909322B WMC ROBOTIC PACK - LF DYNJ902583O
Reason for Recall
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Distribution Pattern
US Nationwide distribution. OUS distribution pending.
Lot / Code Information
DYNJ905836D UDI-DI 10195327517977 Lot 25LBB534 DYNJ905293I UDI-DI 10198459247972 Lot 25KBM585 DYNJT8308 UDI-DI 10198459697135 Lot 26CBD040 CDS860087Q UDI-DI 10198459543005 Lots 25JBV094 25LBP061 DYNJ910084C UDI-DI 10198459597466 Lot 25LBE810 CDS982371I UDI-DI 10198459044106 Lots 25KBH343 26CBN241 CDS920099S UDI-DI 10195327140656 Lot 25KBO172 DYNJT3887 UDI-DI 10198459366871 Lot 25JBX564 DYNJT6876 UDI-DI 10198459583148 Lot 25KBM646 CDS984228K UDI-DI 10198459044113 Lot 26ABF608 DYNJ911843 UDI-DI 10198459555206 Lot 25LBC203 DYKMBNDL165C UDI-DI 10198459634284 Lot 25LBR024 CDS985442J UDI-DI 10198459476686 Lot 25JBT926 DYNJ84725B UDI-DI 10198459366949 Lot 25JBA329 DYNJ910594B UDI-DI 10198459563768 Lot 25KBJ104 DYNJ53711B UDI-DI 10198459023538 Lots 25KBF929 25LBB875 DYNJ83622C UDI-DI 10198459607172 Lots 25LBR740 26CBJ460 DYNJ909322B UDI-DI 10198459443848 Lot 25LBD961 DYNJ902583O UDI-DI 10198459441806 Lot 25LBC041
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.