FDA-Device2026-02-04Class IIPROCESSING DEFECT
Medline medical procedure kits recalled for defective MASTISOL adhesive tubing
Stop using affected Medline procedure kits
Medline distributed three medical procedure convenience kits containing MASTISOL liquid adhesive with a defect: the tubing can crack when the adhesive vial is opened. This affects breast-hernia-port, breast biopsy, and dermatology procedure kits. No injuries have been reported.
- Check if you have one of the affected kits by SKU number: CDS984853L, DYNJ45641B, or DYNJT3658A.
- Do not use the MASTISOL adhesive from these kits if the tubing is cracked or leaking.
- Contact Medline or your hospital procurement department for replacement kits or adhesive.
- Report any problems with the product to Medline or the FDA.
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
1,928 total
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PORT CDS-LF, Kit SKU CDS984853L; 2) BREAST BIOPSY PACK, Kit SKU DYNJ45641B; 3) DERMATOLOGY PACK, Kit SKU DYNJT3658A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1189-2026More Medline recalls
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- 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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