FDA-Device2026-10-21Class IIPROCESSING DEFECT
Medline surgical convenience kits recalled for cannula leaking or breaking risk
What this means
Medline distributed surgical convenience kits containing cannula components that don't meet required safety dimensions. These kits may leak or break during use.
- Check if you have any Medline surgical convenience kits labeled as EAR, CAROTID PACK, FEM CAROTID PACK, or CAROTID CDS-LF (lot numbers available from FDA).
- Do not use affected kits. Contact Medline or your healthcare facility for replacement or guidance.
- Report any leaking, breaking, or patient harm to the FDA MedWatch program or Medline directly.
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
620 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B; 2) EAR, Medline product number/SKU DYNJ909020A; 3) CAROTID PACK, Medline product number/SKU DYNJ42922C; 4) EAR, Medline product number/SKU DYNJ909020; 5) FEM CAROTID PACK, Medline product number/SKU DYNJ65706; 6) CAROTID CDS-LF, Medline product number/SKU CDS983139B.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0173-2027More 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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