Z-3024-2026 Class II Ongoing
FDA device recall Z-3024-2026 was initiated by Medline Industries, LP on July 10, 2026 and is designated Class II. Reason for recall: Kits contain a potentially contaminated component which were recalled by the manufacturer The recall status is ongoing. Affected quantity: 663 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2026
- Initiation Date
- July 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 663 kits
Product Description
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.
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.
Code Information
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), Lot Number 26BBB487; Medline Kit SKU DYNJ911236, UDI/DI 10198459302299 (each) 40198459302290 (case), Lot Number 25IBS529; Medline Kit SKU DYNJ911243, UDI/DI 10198459302329 (each) 40198459302320 (case), Lot Number 26CBM128; Medline Kit SKU DYNJ911243, UDI/DI 10198459302329 (each) 40198459302320 (case), Lot Number 25JBI549; Medline Kit SKU DYNJ911245, UDI/DI 10198459302336 (each) 40198459302337 (case), Lot Number 25IBP079; Medline Kit SKU DYNJ911332, UDI/DI 10198459326103 (each) 40198459326104 (case), Lot Number 25LBC312; Medline Kit SKU DYNJ911332, UDI/DI 10198459326103 (each) 40198459326104 (case), Lot Number 25KBM427; Medline Kit SKU DYNJ911332A, UDI/DI 10198459714511 (each) 40198459714512 (case), Lot Number 26DBO888; Medline Kit SKU DYNJ911332A, UDI/DI 10198459714511 (each) 40198459714512 (case), Lot Number 26DBF153.