Recall Z-3024-2026
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) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAVINCI, Medline Kit SKU DYNJ900949C; 5) THORACIC, Medline Kit SKU DYNJ903470G; 6) CV PART 1 AND 2, Medline Kit SKU DYNJ908879G; 7) GENERAL ROBOTIC, Medline Kit SKU DYNJ910178A; 8) AMB GYN LAPAROSCOPY KT, Medline Kit SKU DYNJ910281B; 9) DIEP FLAP, Medline Kit SKU DYNJ910832A; 10) C-SECTION, Medline Kit SKU DYNJ911236; 11) LAPAROTOMY, Medline Kit SKU DYNJ911243; 12) OPEN HEART A&B, Medline Kit SKU DYNJ911245; 13) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332; 14) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332A.
Codes / lots: Medline Kit SKU DYNJG001030C, UDI/DI 10198459729614 (each) 40198459729615 (case), Lot Number 26CLA636; Medline Kit SKU DYNJT8166, UDI/DI 10198459697739 (each) 40198459697730 (case), Lot Number 26DBG173; Medline Kit SKU DYNJT8166, UDI/DI 10198459697739 (each) 40198459697730 (case), Lot Number 26CBT177; Medline Kit SKU DYNJ47638B, UDI/DI 10198459219221 (each) 40198459219222 (case), Lot Number 26DBL480; Medline Kit SKU DYNJ47638B, UDI/DI 10198459219221 (each) 40198459219222 (case), Lot Number 26CBQ902; Medline Kit SKU DYNJ900949C, UDI/DI 10195327076344 (each) 40195327076345 (case), Lot Number 25IBR180; Medline Kit SKU DYNJ903470G, UDI/DI 10195327678562 (each) 40195327678563 (case), Lot Number 26ADA465; Medline Kit SKU DYNJ908879G, UDI/DI 10198459377419 (each) 40198459377410 (case), Lot Number 25LBU940; Medline Kit SKU DYNJ910178A, UDI/DI 10198459320682 (each) 40198459320683 (case), Lot Number 25IBU845; Medline Kit SKU DYNJ910281B, UDI/DI 10198459586385 (each) 40198459586386 (case), Lot Number 26ABI051; Medline Kit SKU DYNJ910832A, UDI/DI 10198459425653 (each) 40198459425654 (case), Lot Number 25KBH197; Medline Kit SKU DYNJ911236, UDI/DI 10198459302299 (each) 40198459302290 (case)…
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-3024-2026
- Initiated
- July 10, 2026
- Posted by FDA
- August 26, 2026
- Product code
- LRO – General Surgery Tray
- Quantity
- 663 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-3025-2026 Class II | Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 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 |