FDA-Device2026-02-04Class IIPROCESSING DEFECT
Medline circumcision procedure kit recalled for defective adhesive tubing
What this means
Medline distributed circumcision procedure kits (SKU DYNJ16826O) that contained MASTISOL liquid adhesive with a manufacturing defect. The tubing on the adhesive vials can crack when opened, which could affect the sterility and usability of the adhesive during the procedure.
- Do not use circumcision kits with SKU DYNJ16826O and lot numbers 25LMA655 or 25KMC911
- Contact your medical supplier or Medline for a replacement kit
- If you have already opened a kit from these lot numbers, consult with your infection control or quality assurance team
The agency's original wording
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.
Intended for
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: CIRCUMCISION PACK, Kit SKU DYNJ16826O
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1198-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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