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;

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 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 DYNJ04470L, UDI/DI 10198459548031 (each) 40198459548032 (case), Lot number 26AME079; Medline product number/SKU DYNJ44647D, UDI/DI 10198459615085 (each) 40198459615086 (case), Lot number 26AMC530; Medline product number/SKU DYNJ0660029AM, UDI/DI 10198459486296 (each) 40198459486297 (case), Lot number 26AMA935; Medline product number/SKU DYNJ0160327C, UDI/DI 10195327320065 (each) 40195327320066 (case), Lot number 26ADA892; Medline product number/SKU DYNJ60819L, UDI/DI 10198459536113 (each) 40198459536114 (case), Lot number 26ABW172; Medline product number/SKU DYNJ0271227R, UDI/DI 10198459591846 (each) 40198459591847 (case), Lot number 26ABU969; Medline product number/SKU DYNJ81541C, UDI/DI 10198459082832 (each) 40198459082833 (case), Lot number 26ABS893; Medline product number/SKU DYNJ54094F, UDI/DI 10198459286247 (each) 40198459286248 (case), Lot number 26ABR346; Medline product number/SKU DYNJ62055C, UDI/DI 10198459591914 (each) 40198459591915 (case), Lot number 26ABQ526; Medline product number/SKU DYNJ49366, UDI/DI 10888277847583 (each) 40888277847584 (case), Lot number 26ABQ367; Medline product number/SKU DYNJ65416D, UDI/DI 10198459117404 (each) 40198459117405 (case), Lot number 26ABO155; Medline product number/SKU DYNJ908879G, UDI/DI 10198459377419 (each) 40198459377410 (case), Lot number 26ABN783; Medline product number/SKU DYNJ81096B, UDI/DI 10195327590673 (each) 40195327590674 (case), Lot number 26ABM969; Medline product number/SKU DYNJ53741N, UDI/DI 10198459560088 (each) 40198459560089 (case), Lot number 26ABM155; Medline product number/SKU DYNJ54732I, UDI/DI 10195327549664 (each) 40195327549665 (case), Lot number 26ABK432; Medline product number/SKU DYNJ62691F, UDI/DI 10198459501364 (each) 40198459501365 (case), Lot number 26ABK423; Medline product number/SKU DYNJ54734I, UDI/DI 10195327549565 (each) 40195327549566 (case), Lot number 26ABI561; Medline product number/SKU DYNJ42166A, UDI/DI 10888277938281 (each) 40888277938282 (case), Lot number 26ABG526; Medline product number/SKU DYNJ54734I, UDI/DI 10195327549565 (each) 40195327549566 (case), Lot number 26ABD862; Medline product number/SKU DYNJ903745I, UDI/DI 10198459302800 (each) 40198459302801 (case), Lot number 26ABC126; Medline product number/SKU DYNJ21812O, UDI/DI 10198459174483 (each) 40198459174484 (case), Lot number 26ABB509; Medline product number/SKU DYNJ82955C, UDI/DI 10198459496141 (each) 40198459496142 (case), Lot number 25LMH836; Medline product number/SKU DYNJ0199156
Units affected: 36199 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-0176-2027
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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