Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-06-24
Distribution
US Nationwide distribution. OUS distribution pending.
Firm state
IL
Product quantity
49,654 kits total
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Product description
Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A
Code / lot info
EBSI1688 UDI-DI 10653160370130 Lot 2025102890 EBSI1328A UDI-DI 10653160382980 Lot 2025103090
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.