Official recall notice
FDA Recall: Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LI
- Recall date
- 2026-09-02
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Kits contain a potentially contaminated component which were recalled by the manufacturer
Product description
Kits contain a potentially contaminated component which were recalled by the manufacturer
Affected products
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.