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All product recalls associated with EPI Health, LLC.
Total Recalls
1000
Past Year
593
Class I (Serious)
65
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Event Catalog information does not save when copied and transferred from one unit to another.
Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing.
A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.
Potential contamination of the product with latex adhesive residual.
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
The Arial Mobile Application utilizing Apple iOS 17.4 and iOS 17.5 is frequently restarting causing the app to receive alerts for all pending alarm notifications and other events when the app restarts, experience difficulty in placing and maintaining staff-to-staff phone calls, and frequently appears offline while the app restarts.
Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
This recall involves RC4 50, RC4 60, and RC4 65 Junior Ski Boots in sizes 21.5 to 27.5. The RC4 50 and RC4 60 were sold in Rhino Grey and Snow colors. The RC4 65 was sold in yellow. "Fischer" is printed on the lower shell on each boot, and the specific model and name is printed on the outside of the upper cuff, between the two top buckles. The size of the boot is stamped on the sole.
AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.
Hi-Tech E.V.S. is recalling certain 2020-2023 Gladiator and Metrostar fire trucks equipped with Weldon 8X16 Input-Output nodes. In the event of a short circuit or wiring failure, the firmware in the node may fail to shut off the output pin, resulting in overloaded electrical circuits.
There is a potential for cracks on the mount of the front panel of the device.
Cross Contamination with Other Products
Cross Contamination with Other Products
Cross Contamination with Other Products