Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ...
FDA Device Recall #Z-3025-2026 - Class II, July 10, 2026
Recall Summary
| Recall Number | Z-3025-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | July 10, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 1349 kits |
Product Description
Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759; 4) GYN LAPAROSCOPY PACK, Medline Kit SKU DYNJ89781; 5) ROBOT ME RF, Medline Kit SKU DYNJ900203N; 6) GYN LAPAROSCOPY, Medline Kit SKU DYNJ900541Q; 7) ROBOTIC, Medline Kit SKU DYNJ903485K; 8) ROBOTIC GYN, Medline Kit SKU DYNJ905230K; 9) LAPAROSCOPIC GYN AND COLON, Medline Kit SKU DYNJ906013I; 10) GYN LAPAROSCOPIC PACK, Medline Kit SKU DYNJ909394B; 11) GYN ROBOTIC, Medline Kit SKU DYNJ909526B; 12) GYN ROBOTIC, Medline Kit SKU DYNJ909526C; 13) GYN ONC ROBOTIC, Medline Kit SKU DYNJ910180; 14) GYN ROBOTIC, Medline Kit SKU DYNJ910181; 15) GYN ROBOTIC, Medline Kit SKU DYNJ910181A; 16) ROBOTICS, Medline Kit SKU DYNJ912062.
Reason for Recall
Kits contain a potentially contaminated component which were recalled by the manufacturer
Distribution Pattern
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
Lot / Code Information
Medline Kit SKU CDS982888Q, UDI/DI 10198459521959 (each) 40198459521950 (case), Lot Number 26FBU894; Medline Kit SKU CDS982888Q, UDI/DI 10198459521959 (each) 40198459521950 (case), Lot Number 26BBF959; Medline Kit SKU DYNJ43837D, UDI/DI 10195327657222 (each) 40195327657223 (case), Lot Number 25KMH001; Medline Kit SKU DYNJ89759, UDI/DI 10198459289286 (each) 40198459289287 (case), Lot Number 26ABN671; Medline Kit SKU DYNJ89759, UDI/DI 10198459289286 (each) 40198459289287 (case), Lot Number 25JBT511; Medline Kit SKU DYNJ89781, UDI/DI 10198459289521 (each) 40198459289522 (case), Lot Number 26DBT722; Medline Kit SKU DYNJ89781, UDI/DI 10198459289521 (each) 40198459289522 (case), Lot Number 25JBL333; Medline Kit SKU DYNJ900203N, UDI/DI 10198459510144 (each) 40198459510145 (case), Lot Number 25KBF320; Medline Kit SKU DYNJ900203N, UDI/DI 10198459510144 (each) 40198459510145 (case), Lot Number 25JBS159; Medline Kit SKU DYNJ900541Q, UDI/DI 10198459602283 (each) 40198459602284 (case), Lot Number 26AMH304; Medline Kit SKU DYNJ900541Q, UDI/DI 10198459602283 (each) 40198459602284 (case), Lot Number 26AME001; Medline Kit SKU DYNJ903485K, UDI/DI 10198459255083 (each) 40198459255084 (case), Lot Number 26ADA977; Medline Kit SKU DYNJ903485K, UDI/DI 10198459255083 (each) 40198459255084 (case), Lot Number 25HDB674; Medline Kit SKU DYNJ905230K, UDI/DI 10198459520532 (each) 40198459520533 (case), Lot Number 25KBN172; Medline Kit SKU DYNJ906013I, UDI/DI 10198459501616 (each) 40198459501617 (case), Lot Number 25KBH190; Medline Kit SKU DYNJ909394B, UDI/DI 10198459556579 (each) 40198459556570 (case), Lot Number 25KBE469; Medline Kit SKU DYNJ909526B, UDI/DI 10198459539886 (each) 40198459539887 (case), Lot Number 26AMD191; Medline Kit SKU DYNJ909526C, UDI/DI 10198459716799 (each) 40198459716790 (case), Lot Number 26DMF990; Medline Kit SKU DYNJ910180, UDI/DI 10195327609627 (each) 40195327609628 (case), Lot Number 25IBP437; Medline Kit SKU DYNJ910181, UDI/DI 10195327609733 (each) 40195327609734 (case), Lot Number 25ILA566; Medline Kit SKU DYNJ910181A, UDI/DI 10198459556586 (each) 40198459556587 (case), Lot Number 25KLA664; DYNJ912062, UDI/DI 10198459611025 (each) 40198459611026 (case), Lot Number 26CBS107.
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2993-2026 | Class II | Medline breathing circuits labeled as: 1) ME... | Jul 13, 2026 |
| Z-2991-2026 | Class II | Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATOR... | Jul 13, 2026 |
| Z-2992-2026 | Class II | Medline breathing circuits labeled as: 1) HU... | Jul 13, 2026 |
| Z-3027-2026 | Class II | Medline convenience kits labeled as: 1) LAVH... | Jul 10, 2026 |
| Z-3021-2026 | Class II | Medline convenience kits labeled as: MAJOR HEA... | Jul 10, 2026 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately, you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.