Official recall notice
FDA Recall: Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROB
- 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 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.