Device recall

Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A

FDA recall source

Recall number

Z-3207-2026

Event id

99667

Status

Ongoing

FDA classification

Class II

Recalling firm

Medline Industries, LP

Report date

Sep 23, 2026

Posted

Sep 16, 2026

Initiated

Jul 31, 2026

Center classification date

Sep 16, 2026

Product code

OFT

Device type

Spinal Epidural Anesthesia Kit

Reason

Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.

Root cause

Under Investigation by firm

Quantity

341

Code info

UDI-DI 10195327506506 Lot 25BBK494

Distribution

US Nationwide distribution in states of Arkansas, Florida, North Carolina, Maryland, and Texas.

Voluntary or mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States