Z-2446-2026 Class II Ongoing

Recalled by Medline Industries, LP — Northfield, IL

FDA device recall Z-2446-2026 was initiated by Medline Industries, LP on Apr 27, 2026 and is designated Class II. Reason for recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. The recall status is ongoing. Affected quantity: 49,654 kits total.

Recall Details

Product Type
Devices
Report Date
Jun 24, 2026
Initiation Date
Apr 27, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
49,654 kits total

Product Description

Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION DYNJ905094B C-SECTION RECOVERY #2 CDS820091P

Reason for Recall

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Distribution Pattern

US Nationwide distribution. OUS distribution pending.

Code Information

CDS985505G UDI-DI 10195327412555 Lot 26AMC363 DYNJ68260D UDI-DI 10195327506513 Lot 25KBE168 DYNJ905094B UDI-DI 10193489858174 Lot 25KMB136 CDS820091P UDI-DI 10195327403539 Lots 26BBO404 26CBN891

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2446-2026
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.