Medline Industries, LP recalls Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A &#38

Recalling company

Medline Industries, LP

Product

Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PACK, Medline Product number/SKU DYNJ85751; 4) OPEN HEART PACK, Medline Product number/SKU DYNJ53741N; 5) OPEN HEART PACK 1&2, Medline Product number/SKU DYNJ80701A; 6) VEIN PACK, Medline Product number/SKU DYNJ67308C; 7) OPEN HEART PACK, Medline Product number/SKU DYNJ89451B; 8) VASCULAR TRAY-LF, Medline Product number/SKU DYNJ42166A; 9) ENDOSCOPIC VEIN HARVEST PK, Medline Product number/SKU DYNJ67363C; 10) ENDOSCOPIC VEIN HARVEST PK, Medline Product number/SKU DYNJ67363B; 11) LIVER TRANSPLANT PACK B, Medline Product number/SKU DYNJ65779B; 12) CABG PACK-LF, Medline Product number/SKU DYNJ47661J; 13) VEIN HARVEST PACK, Medline Product number/SKU DYNJ04470L; 14) CARDIAC PACK, Medline Product number/SKU DYNJ44647D; 15) GM OPEN HEART ACC PACK-LF, Medline Product number/SKU DYNJ0660029AM; 16) CARDIOVASCULAR PACK-LF, Medline Product number/SKU DYNJ0160327C; 17) GOOD SHEPHERD OPEN HEART, Medline Product number/SKU DYNJ60819L; 18) OPEN HEART PACK, Medline Product number/SKU DYNJ0271227R; 19) OPEN HEART PACK, Medline Product number/SKU DYNJ81541C; 20) TAVR PACK, Medline Product number/SKU DYNJ54094F; 21) TRANSPLANT BACKTABLE PACK, Medline Product number/SKU DYNJ62055C; 22) VASCULAR, Medline Product number/SKU DYNJ49366; 23) BACK TABLE TRAY, Medline Product number/SKU DYNJ65416D; 24) CV PART 1 AND 2, Medline Product number/SKU DYNJ908879G; 25) OPEN HEART A B PACK, Medline Product number/SKU DYNJ81096B; 26) KIDNEY, Medline Product number/SKU DYNJ54732I; 27) ABDOMINAL PRESEVERVATION PACK, Medline Product number/SKU DYNJ62691F; 28) LIVER PACK SAFETY, Medline Product number/SKU DYNJ54734I; 29) CV PROCEDURE PART A, Medline Product number/SKU DYNJ903745I;

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

36199 kits

Lot / codes

Medline product number/SKU DYNJ04584L, UDI/DI 10198459212291 (each) 40198459212292 (case), Lot number 26DMA968; Medline product number/SKU DYNJT5715A, UDI/DI 10198459505126 (each) 40198459505127 (case), Lot number 26CMI506; Medline product number/SKU DYNJ85751, UDI/DI 10195327542917 (each) 40195327542918 (case), Lot number 26BMB785; Medline product number/SKU DYNJ53741N, UDI/DI 10198459560088 (each) 40198459560089 (case), Lot number 26BBG793; Medline product number/SKU DYNJ80701A, UDI/DI 10198459026195 (each) 40198459026196 (case), Lot number 26BBF945; Medline product number/SKU DYNJ67308C, UDI/DI 10198459676666 (each) 40198459676667 (case), Lot number 26BBF661; Medline product number/SKU DYNJ89451B, UDI/DI 10198459637674 (each) 40198459637675 (case), Lot number 26BBC903; Medline product number/SKU DYNJ42166A, UDI/DI 10888277938281 (each) 40888277938282 (case), Lot number 26BBB320; Medline product number/SKU DYNJ67363C, UDI/DI 10198459652226 (each) 40198459652227 (case), Lot number 26AML066; Medline product number/SKU DYNJ67363B, UDI/DI 10198459259081 (each) 40198459259082 (case), Lot number 26AMK067; Medline product number/SKU DYNJ65779B, UDI/DI 10195327571733 (each) 40195327571734 (case), Lot number 26AMI446; Medline product number/SKU DYNJ47661J, UDI/DI 10198459525704 (each) 40198459525705 (case), Lot number 26AMF686; Medline product number/SKU DYNJ04584L, UDI/DI 10198459212291 (each) 40198459212292 (case), Lot number 26AMF245; Medline product number/SKU DYNJ0

Company location

Northfield, IL

Recall type

Voluntary: Firm initiated

Recall number

Z-0176-2027

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0176-2027 in the FDA Enforcement Report. Also see FDA recall press releases.