Z-1192-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 4, 2026
- Initiation Date
- December 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66 units
Product Description
Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AUG PACK, Kit SKU DYNJ59250I; 5) KMC PLASTIC/GEN PACK-LF, Kit SKU DYNJ65980J; 6) PLASTICS PACK, Kit SKU DYNJ68288A; 7) IMPLANT REMOVAL KIT, Kit SKU MNS13035; 8) PLASTICS PACK-LF, Kit SKU PHS41746D.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Medline Kit SKU DYNJ0660040R: UDI/DI 10889942220083 (EA) 40889942220084 (CS), Lot Number 25KMG652; Medline Kit SKU DYNJ39225K: UDI/DI 10198459102257 (EA) 40198459102258 (CS), Lot Number 25JMJ958; Medline Kit SKU DYNJ39225K: UDI/DI 10198459102257 (EA) 40198459102258 (CS), Lot Number 25KMJ566; Medline Kit SKU DYNJ46620I: UDI/DI 10198459404009 (EA) 40198459404000 (CS), Lot Number 25KBE927; Medline Kit SKU DYNJ59250I: UDI/DI 10198459359941 (EA) 40198459359942 (CS), Lot Number 25KMB767; Medline Kit SKU DYNJ65980J: UDI/DI 10198459423727 (EA) 40198459423728 (CS), Lot Number 25KMJ630; Medline Kit SKU DYNJ68288A: UDI/DI 10195327056995 (EA) 40195327056996 (CS), Lot Number 25KMF183; Medline Kit SKU MNS13035: UDI/DI 10653160990482 (EA) 40653160990483 (CS), Lot Number 25KME754; Medline Kit SKU PHS41746D: UDI/DI 10198459438820 (EA) 40198459438821 (CS), Lot Number 25KMD226.