EKOS Corporation Recalls EKOS Carts Due to Missing Wheel Washers
EKOS Corporation is recalling 455 EKOS carts because missing washers may cause wheels to wear or dislodge, leading to equipment failure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves mechanical failure (wheel dislodgement) without reported injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
EKOS Corporation is recalling 455 EKOS carts, catalog number 700-60101, due to a safety concern regarding the casters. The casters on these carts may be missing washers, which can cause premature wear and dislodgement of the casters or wheels, leading to failure of the cart.
The affected carts are custom infusion stands used to hold and transport the EkoSonic Control Unit. They are designed with three poles for infusion pumps and fluid bags, a tray for the control unit, and a base for an Uninterruptable Power Supply (UPS). The carts mount on four wheels, two of which are locking and two are non-locking.
The recall covers units distributed nationwide in the United States, including the District of Columbia and the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY. The specific lot numbers affected are 030915, 032615, 040915, 061515, 071515, 081715, 103015, 120715, 010416, 011816, 022216, 032116, and 052416. Users should contact EKOS Corporation for further instructions on how to resolve this issue.
The recalled product
- Product
- The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and…
- Manufacturer
- EKOS Corporation
- Category
- Medical Device — Infusion Cart
- Affected units
- 455
Distribution
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