Remel, Inc

10 FDA enforcement actions

10 Total Recalls

0 Class I

10 Class II

0 Class III

Firm Details

Product Types: device
States: KS

All Recalls

Class II: Risk 11/12/2025 device

Products may contain contamination, which may result in a darker or brown media color.
Class II: Risk 07/11/2025 device

The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class II: Risk 07/11/2025 device

The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class II: Risk 07/11/2025 device

The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class II: Risk 07/11/2025 device

The products may contain surface and subsurface contamination of Listeria monocytogenes.
Class II: Risk 05/01/2025 device

Product may have an off color affecting perfomance
Class II: Risk 02/13/2025 device

Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Class II: Risk 02/13/2025 device

Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Class II: Risk 02/12/2025 device

Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
Class II: Risk 09/20/2024 device

A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.