FDA Medical devices recall ·
Medline medical procedure convenience kits labeled as: 1) MEM… recall
- Recall number
- Z-1192-2026
- Date
- (initiated December 12, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 66 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1192-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.