FDA Device Recalls

Recalls /

#218618

Product

Campy CVA Medium 100/PK, R01272

FDA product code
JSJCulture Media, Selective And Non-Differential
Device class
Class 1
Medical specialty
Microbiology
Affected lot / code info
UDI-DI 848838001055 Lot R01272 lot 339135 Expired January 12, 2026

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On February 5, 2026, the firm notified affected customers via Urgent Medical Device Recall letter. Customers were instructed to review test results and destroy any remaining inventory of the affected lot.

Recalling firm

Firm
Remel, Inc
Address
12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

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

Timeline

Recall initiated
2026-02-05
Posted by FDA
2026-02-26
Status

Source: openFDA Device Recall endpoint. Recall record ID #218618. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.