FDA-Device2026-02-04Class IIPROCESSING DEFECT

Medline circumcision procedure kit recalled for defective adhesive tubing

OTHERNationwide distribution

Stop using Medline circumcision procedure kit

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
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.

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-1198-2026

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