FDA-Device2026-02-04Class IIPROCESSING DEFECT
Medline medical procedure kits recalled for defective adhesive tubing
Stop using affected Medline procedure kits
Medline distributed nine types of medical procedure convenience kits containing MASTISOL liquid adhesive. The adhesive vials have defective tubing that can crack when used, potentially compromising the sterility and function of the kits. About 40 units were affected.
- Check if you have any of the listed Medline kit SKUs (CDS984347O, CDS984857N, DYNJ0966130K, DYNJ51440B, DYNJ58742J, DYNJ63781B, DYNJ82751B, DYNJ82753C, or DYNJ907206G).
- Do not use kits with the affected lot numbers listed in the recall notice.
- Contact Medline Industries for instructions on returning or replacing the kits.
- If a kit was already used, inform your healthcare provider.
Hazard
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
40 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, Kit SKU DYNJ63781B; 7) NECK PACK, Kit SKU DYNJ82751B; 8) NOSE PACK, Kit SKU DYNJ82753C; 9) WMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1190-2026More Medline recalls
- FDA-PR2026-08-05Medline Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits recalled for connector overheating risk
- FDA-Device2026-07-29Medline surgical convenience kits recalled for quality issues in anesthetic component
- FDA-Device2026-07-29Medline NEURO PACK medical kits recalled for Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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