FDA recall record · openFDA

Remel, Inc

14 FDA recalls on record (2023–2026) — 14 device. 14 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

The products may contain surface and subsurface contamination of Listeria monocytogenes. 4

Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediatel 2

Products may report incorrect AST results during quality control. Health consequences may include delayed response or th 1

Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard. 1

The test medium may not perform as intended. 1

Recalls

Yeastone Broth, 11ML, 10/BOX YY3462 Class II 2026-03-24 Campy CVA Medium 100/PK, R01272 Class II 2026-02-05 remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use Class II 2025-02-13 Blood Agar,5% Sheep Blood 100/PK, Product Number R01202 Class II 2025-07-11 Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Se Class II 2025-02-12 Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; inv Class II 2025-05-01 Blood/MacConkey Biplate 100/PK, Product Number R02049 Class II 2025-07-11 Strep Selective II Agar, Product Number R01859 Class II 2025-07-11 Blood/EMB, Levine 100/PK, Product Number R02041 Class II 2025-07-11 remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use Class II 2025-02-13 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450 Class II 2025-11-12 remel BactiDrop Acridine Orange, REF 21502, 50 per package. Class II 2024-09-20 Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, Class II 2023-05-31 remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containi Class II 2023-08-14

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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