Etac¿ Ono Walker — Class II medical device recall Z-2014-2012
Terminated recall by Etac Supply Center Ab, reported 2012-07-25, distributed nationwide. The recall has been initiated because there is the potential that users may fall and become injured, with the
| Recall number | Z-2014-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Etac Supply Center Ab, Anderstorp, Sweden |
| Recall initiated | 2012-04-06 |
| Classified | 2012-07-14 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2013-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CN, CO, DE, DK, EE, ES, FI, FR, GR, IE, IL, IS, IT, JP, KR, KW, LT, LU, LV, MY, NL, NO, PL, PT, RU, SA, SE, SI, SK, TH |
| Reason classes | device malfunction |
| Model numbers | 15030102-15, 15030103-15, 15030202-15, 15030403-15, 15031003-14, 15040105-14, 15040105-33, 15040301-14, 15040301-33, 15110101-18 |
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.
Reason for recall
The recall has been initiated because there is the potential that users may fall and become injured, with the potential for serious injury, including bone fracture. One death occurred in a user fall incident, but it is unclear whether the fall was caused by the loss of a wheel. Among the walkers distributed worldwide, Etac¿ has received a total of 49 reports from Europe and Japan of wheels falling
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2014-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.