Etac Walker Recall Due to Wheel Detachment and Fall Risk
Etac Supply Center Ab is recalling Ono, Avant, and Salsa walkers because wheels may fall off, posing a risk of serious injury or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that one death occurred in a user fall incident, which mandates a Critical severity score of 5 according to the rubric.
Plain-English summary
Etac Supply Center Ab is recalling approximately 226,695 units of Etac Ono, Avant, and Salsa four-wheeled walkers. These devices are intended as walking aids for indoor and outdoor use for persons weighing up to 125 kg. The recall covers units distributed in the United States and numerous countries worldwide, including those in Europe, Asia, and the Middle East.
The recall was initiated because there is a potential for users to fall and become injured if a wheel falls off the walker. The hazard includes the potential for serious injury, such as bone fractures. Etac has received 49 reports from Europe and Japan regarding wheels falling off. One death occurred in a user fall incident, although it is unclear whether the fall was caused by the loss of a wheel.
Consumers should stop using the affected walkers immediately. The specific model numbers involved in this recall are 15030102-15, 15030103-15, 15030202-15, 15030403-15, 15031003-14, 15040105-14, 15040105-33, 15040301-14, 15040301-33, and 15110101-18.
The recalled product
- Product
- Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG.
- Manufacturer
- Etac Supply Center Ab
- Category
- Medical Device — Mobility Aids
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Model numbers: 15030102-15
- 15030103-15
- 15030202-15
- 15030403-15
- 15031003-14
- 15040105-14
- 15040105-33
- 15040301-14
- 15040301-33
- and 15110101-18.
Distribution
Distributed nationwide across the United States.
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