Recall Z-0585-2026— Remel, Inc

Name: FDA recall Z-0585-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-12

Class II · Ongoing

Class II FDA medical device recall by Remel, Inc, initiated 2025-11-12. It names 2 FDA 510(k) clearances: K802957, K790687. Product: 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450. Reason: Products may contain contamination, which may result in a darker or brown media color..

Recalling firm: Remel, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-11-12
Firm location: Lenexa, KS, United States

510(k) clearances named in this recall

2 on FDA's record

K802957 — MUELLER HINTON BROTHGibco Laboratories Life Technologies, Inc.·cleared 1980-12-22
K790687 — BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2Gibco Laboratories Life Technologies, Inc.·cleared 1979-05-03

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

1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450

Reason for recall

Products may contain contamination, which may result in a darker or brown media color.

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