Official recall notice

FDA DeviceClass IINotable

FDA Recall: Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATI

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 CDS982040U, UDI/DI 10198459385421 (each) 40198459385422 (case), Lot Number 26AMC355; Medline Kit SKU DYNJ89608, UDI/DI 10198459279324 (each) 40198459279325 (case), Lot Number 25JBR465; Medline Kit SKU DYNJ903479L, UDI/DI 10198459255250 (each) 40198459255251 (case), Lot Number 25LMB480; Medline Kit SKU DYNJ903479M, UDI/DI 10198459790591 (each) 40198459790592 (case), Lot Number 26FMB173.

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