Official recall notice

FDA DeviceClass IINotable

FDA Recall: Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR

Recall date
2026-09-02
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 CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Number 25LMF531; Medline Kit SKU CDS982035Y, UDI/DI 10198459385636 (each) 40198459385637 (case), Lot Number 25JML577; Medline Kit SKU DYNJT6104, UDI/DI 10198459539374 (each) 40198459539375 (case), Lot Number 25JBM473; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26DDB085; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26DDA481; Medline Kit SKU DYNJ903471I, UDI/DI 10198459255069 (each) 40198459255060 (case), Lot Number 26CDA102; Medline Kit SKU DYNJ906496K, UDI/DI 10198459419614 (each) 40198459419615 (case), Lot Number 25KLA074.

Verify with the official notice →
Share:

Related Recalls

2026-09-09 · FDA_DEVICE
FDA Recall: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DY
Medline Industries, LP
2026-09-09 · FDA_DEVICE
FDA Recall: Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A
Medline Industries, LP
2026-09-09 · FDA_DEVICE
FDA Recall: Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT,
Medline Industries, LP
2026-09-09 · FDA_DEVICE
FDA Recall: Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT, Catalog Number
Medline Industries, LP