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;

Class II

Recalling firm: Medline Industries, LP
Reason for recall: 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.
Affected products (lot / model / serial): 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 (case), Lot Number 26CMG812; Medline product kit number/SKU DYNJ45122C, UDI/DI 10193489496369 (each) 40193489496360 (case), Lot Number 26CMG766; Medline product kit number/SKU DYNJ903705K, UDI/DI 10195327615604 (each) 40195327615605 (case), Lot Number 26CMB724; Medline product kit number/SKU CDS981248M, UDI/DI 10198459117336 (each) 40198459117337 (case), Lot Number 26CMA585; Medline product kit number/SKU DYNJ911483A, UDI/DI 10198459515095 (each) 40198459515096 (case), Lot Number 26CLB089; Medline product kit number/SKU CDS985355I, UDI/DI 10198459288081 (each) 40198459288082 (case), Lot Number 26CDA736; Medline product kit number/SKU DYNJ908168I, UDI/DI 10198459433085 (each) 40198459433086 (case), Lot Number 26CBQ271; Medline product kit number/SKU DYNJ902898I, UDI/DI 10198459497230 (each) 40198459497231 (case), Lot Number 26CBN774; Medline product kit number/SKU DYNJ911488A, UDI/DI 10198459666933 (each) 40198459666934 (case), Lot Number 26CBN470; Medline product kit number/SKU DYNJ900523B, UDI/DI 10195327628703 (each) 40195327628704 (case), Lot Number 26CBL270; Medline product kit number/SKU DYNJ911488A, UDI/DI 10198459666933 (each) 40198459666934 (case), Lot Number 26CBK492; Medline product kit number/SKU DYNJ911274C, UDI/DI 10198459594908 (each) 40198459594909 (case), Lot Number 26CBK471; Medline product kit number/SKU CDS840094R, UDI/DI 10198459248122 (each) 40198459248123 (case), Lot Number 26CBA720; Medline product kit number/SKU CDS840171AG, UDI/DI 10198459640957 (each) 40198459640958 (case), Lot Number 26BMK455; Medline product kit number/SKU DYNJ903705K, UDI/DI 10195327615604 (each) 40195327615605 (case), Lot Number 26BMJ864; Medline product kit number/SKU CDS840171AG, UDI/DI 10198459640957 (each) 40198459640958 (case), Lot Number 26BMI610; Medline product kit number/SKU CDS840171AG, UDI/DI 10198459640957 (each) 40198459640958 (case), Lot Number 26BMI603; Medline product kit number/SKU CDS840379O, UDI/DI 10198459229169 (each) 40198459229160 (case), Lot Number 26BMH466; Medline product kit number/SKU DYNJ0349727D, UDI/DI 10195327000158 (each) 40195327000159 (case), Lot Number 26BMD752; Medline product kit number/SKU DYNJ19906L, UDI/DI 10198459180873 (each) 40198459180874 (case), Lot Number 26BMC966; Medline product kit number/SKU DYNJ0824648K, UDI/DI 10193489730371 (each) 40193489730372 (case), Lot Number 26BMC734; Medline product kit number/SKU DYNJ22721N, UDI/DI 10198459229176 (each) 40198459229177 (case), Lot Number 26BMA364;
Units affected: 193374 kits
Distribution pattern: US Nationwide distribution.
Firm location: Northfield, IL, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type: Devices
Status: Ongoing
Recall number: Z-0170-2027
Recall initiated: September 2, 2026
FDA classification date: October 15, 2026
FDA report date: October 21, 2026
FDA event ID: 99886
Last updated on HTM Vibe: October 27, 2026

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