Recall Z-2224-2025— Remel, Inc

Name: FDA recall Z-2224-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-11

Class II · Ongoing

Class II FDA medical device recall by Remel, Inc, initiated 2025-07-11. It names one FDA 510(k) clearance: K843193. Product: Strep Selective II Agar, Product Number R01859. Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes..

Recalling firm: Remel, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-07-11
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

1 on FDA's record

K843193 — STREP SELECTIVE IIRemel Co.·cleared 1984-09-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Strep Selective II Agar, Product Number R01859

Reason for recall

The products may contain surface and subsurface contamination of Listeria monocytogenes.

Data sourced from openFDA. This site is unofficial and independent of the FDA.