Z-1195-2026 Class II Ongoing
FDA device recall Z-1195-2026 was initiated by Medline Industries, LP on December 12, 2025 and is designated Class II. 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 Liqui… The recall status is ongoing. Affected quantity: 1,928 total.
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
- 1,928 total
Product Description
Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A.
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 DT22880: UDI/DI 10653160995470 (EA) 40653160995471 (CS), Lot Number 25KMJ441; Medline Kit SKU DYNDC3283A: UDI/DI 10198459313240 (EA) 40198459313241 (CS), Lot Number 25KMH515.