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 required dimensional standards. These components may leak or break during surgical use.
- Check if your facility received any of the affected Medline kits (SKUs DYNJ0656274AC, DYNJ0656274AB, DYNJ0656274AA, or DYNJ35312I).
- Do not use affected kits in surgical procedures.
- Contact Medline at the recall notice for return and replacement options.
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
472 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC; 2) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AB; 3) CATH LAB ENDO AAA, Medline product number/SKU DYNJ35312I; 4) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0174-2027More 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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