Recall Z-3025-2026
Medline Industries, LP · initiated July 10, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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…
Reason for recall
Kits contain a potentially contaminated component which were recalled by the manufacturer
FDA-determined cause: Process change control
Action taken
Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/1/2026 via USPS and email. The notice explained the issue, potential hazard, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-120-FG-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-3025-2026
- Initiated
- July 10, 2026
- Posted by FDA
- August 26, 2026
- Product code
- OHD – Gynecological Laparoscopic Kit
- Quantity
- 1349 kits
- Distribution
- 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.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3019-2026 Class II | Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3020-2026 Class II | Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3021-2026 Class II | Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991SKits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3022-2026 Class II | Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3023-2026 Class II | Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375MKits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3024-2026 Class II | Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3026-2026 Class II | Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3027-2026 Class II | Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3028-2026 Class II | Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |
| Z-3029-2026 Class II | Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON…Kits contain a potentially contaminated component which were recalled by the manufacturer | 07/10/2026Open, Classified |