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Recall Observatory FDA recall evidence

Device product

Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O

Z-1198-2026

December 12, 2025

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98226
Status
Ongoing
Classification
Class II
Quantity
1,928 total
Official record key
device-enforcement:Z-1198-2026

Official wording

Reason: 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.

Code information: Medline Kit SKU DYNJ16826O: UDI/DI 10195327412067 (EA) 40195327412068 (CS), Lot Number 25LMA655; Medline Kit SKU DYNJ16826O: UDI/DI 10195327412067 (EA) 40195327412068 (CS), Lot Number 25KMC911.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.