FDA Enforcement Class II Ongoing

Campy CVA Medium 100/PK, R01272

Recall: Z-1474-2026 · Reported March 4, 2026

Enforcement

Recall Number
Z-1474-2026
Event ID
98403
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Remel, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
March 4, 2026
Initiation Date
February 5, 2026
Classification Date
February 26, 2026
Address
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

Description

Campy CVA Medium 100/PK, R01272

Reason

Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.

Code Info

UDI-DI 848838001055 Lot R01272 lot 339135 Expired January 12, 2026

Distribution

US Nationwide distribution in the states of AZ, CO, IL, NJ, OH, TN, WA.

Quantity

97