This is part of a larger recall. The most authoritative record is FDA-Device / Z-0169-2027.
FDA-Device2026-10-21Class IIPROCESSING DEFECT
Medline surgical convenience kits recalled for cannula components that may leak or break
What this means
Medline distributed surgical convenience kits containing cannula components that do not meet international safety standards. These components may leak or break during cardiac, vascular, and transplant procedures.
- Check if your facility has any of the affected Medline surgical kits using the product numbers listed in the recall notice.
- Do not use any affected kits for patient procedures.
- Contact Medline for instructions on returning or replacing affected kits.
- Review the complete list of affected product numbers and lot numbers on the FDA or Medline website.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
36199 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0176-2027More Medline recalls
- FDA-Device2026-10-22Medline medical convenience kits recalled for difficult removal and adhesive residue
- FDA-Device2026-10-22Medline sterile C-section surgical drape recalled for difficult removal and skin adhesive residue
- FDA-Device2026-10-22Medline medical convenience kits recalled for difficult removal and adhesive residue
- FDA-Device2026-10-22Medline surgical convenience kits recalled for difficult removal and adhesive residue
- FDA-Device2026-10-22Medline tubal ligation surgical kit recalled for difficult removal and skin adhesive residue
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