Medline Industries, LP recalls Medline surgical convenience kits labeled as: 1) OPEN HEART CDS

Recalling company

Medline Industries, LP

Product

Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU CDS840171AG; 3) MHC AV FISTULA, Medline product number/SKU DYNJ903705K; 4) PERIPHERAL VASC MAJR-LF, Medline product number/SKU CDS840379O; 5) MINOR VASCULAR PACK-LF, Medline product number/SKU DYNJ0349727D; 6) SJHC VASCULAR PK-LF, Medline product number/SKU DYNJ19906L; 7) CABG PACK-LF, Medline product number/SKU DYNJ0824648K; 8) PERIPHERAL VASC MNR-LF, Medline product number/SKU DYNJ22721N; 9) HEART A PACK, Medline product number/SKU DYNJ0362405S; 10) OPEN HEART, Medline product number/SKU DYNJ907676I; 11) FEM POP MARYVIEW, Medline product number/SKU DYNJ911714; 12) CABG PACK, Medline product number/SKU DYNJ906346G; 13) DEBOER HEART MAIN, Medline product number/SKU DYNJ907914I; 14) OPEN HEART A & B PACK, Medline product number/SKU DYNJ9718008AU; 15) OPEN HEART, Medline product number/SKU DYNJ911483A; 16) CABG ACCESSORY PACK, Medline product number/SKU DYNJ59265; 17) HEART, Medline product number/SKU DYNJ908779B; 18) CARDIOVASCULAR PACK, Medline product number/SKU DYNJ69507F; 19) OFF PUMP CABG CDS, Medline product number/SKU CDS840087AN; 20) PACK CABG CHRG, Medline product number/SKU DYNJ905683D; 21) HEART CDS, Medline product number/SKU CDS840179N;

Reason

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Sep 2, 2026

Reported

Oct 21, 2026

Distribution

US Nationwide distribution.

Status

Ongoing

Quantity

193374 kits

Lot / codes

Medline product kit number/SKU CDS840076AD, UDI/DI 10198459311536 (each) 40198459311537 (case), Lot Number 26HBD144; Medline product kit number/SKU CDS840393P, UDI/DI 10198459405266 (each) 40198459405267 (case), Lot Number 26FMA487; Medline product kit number/SKU CDS840132RFP, UDI/DI 10195327669324 (each) 40195327669325 (case), Lot Number 26FBR713; Medline product kit number/SKU DYNJ906775G, UDI/DI 10198459506390 (each) 40198459506391 (case), Lot Number 26DMK788; Medline product kit number/SKU DYNJ906775G, UDI/DI 10198459506390 (each) 40198459506391 (case), Lot Number 26DMG190; Medline product kit number/SKU CDS840393P, UDI/DI 10198459405266 (each) 40198459405267 (case), Lot Number 26DMA855; Medline product kit number/SKU DYNJ902765G, UDI/DI 10198459161599 (each) 40198459161590 (case), Lot Number 26DBO919; Medline product kit number/SKU DYNJ907552B, UDI/DI 10195327260750 (each) 40195327260751 (case), Lot Number 26CML345; Medline product kit number/SKU CDS840393P, UDI/DI 10198459405266 (each) 40198459405267 (case), Lot Number 26CML246; Medline product kit number/SKU CDS840393P, UDI/DI 10198459405266 (each) 40198459405267 (case), Lot Number 26CMH715; Medline product kit number/SKU DYNJ22721N, UDI/DI 10198459229176 (each) 40198459229177 (case), Lot Number 26CMH546; Medline product kit number/SKU CDS840171AG, UDI/DI 10198459640957 (each) 40198459640958 (case), Lot Number 26CMG918; Medline product kit number/SKU DYNJ36240P, UDI/DI 10198459728716 (each) 40198459728717 (

Company location

Northfield, IL

Recall type

Voluntary: Firm initiated

Recall number

Z-0170-2027

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0170-2027 in the FDA Enforcement Report. Also see FDA recall press releases.