Loading...
Loading...
All product recalls associated with ela Medical Llc.
Total Recalls
1000
Past Year
1000
Class I (Serious)
34
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.
Devices manufactured prior to August 2004 may experience premature battery depletion and/or extended charge times which may affect the device's ability to function.
Sterility may be compromised.
The potential exists for the AI1000 workstation to mix images from one study with images from another study. Mixed studies could be from the same patient or from different patients. Mixed patient images could compromise patient condition or diagnosis and treatment.
The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors.
The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.
Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
Product sterility may be compromised due incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).
There is a lack of assurance of sterility for parts of these lots of product.
Customer complaints state the needle had separated from the hub, resulting in blood exposure and/or dislocation of the needle.
The firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line. In some instances when the door cord is installed with little or no slack outside the upper decor piece, the cord has been known to fail causing a short in the wiring at the pivot point in the cord.
The firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line. In some instances when the door cord is installed with little or no slack outside the upper decor piece, the cord has been known to fail causing a short in the wiring at the pivot point in the cord.
Cracked hubs/handles and/or improper peeling of the sheath during use.
Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
Actuating tab may detach from the stopcock body, allowing fluid leak.