OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console… — Class II medical device recall Z-0335-2022
Ongoing recall by Osteomed, LLC, reported 2021-12-15, distributed nationwide. Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocke
| Recall number | Z-0335-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Osteomed, LLC, Addison, TX, United States |
| Recall initiated | 2021-10-28 |
| Classified | 2021-12-06 |
| Reported by FDA | 2021-12-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BO, BR, CA, CL, CO, DE, DO, EC, ES, GB, GT, ID, IT, JP, KR, KW, LT, MX, MY, RU, TH, TR, VE |
| Serial numbers | 0002001, 0004002, 0008006, 0023005S, 0029001, 0051007S, 0103013, 0106001, 0142015, 0203013, 0204001, 0204002, 0208003, 0208021S, 0212002S, 0216010, 0222025, 0232001, 0244009, 0332004, 0422006, 0423001, 0423005, 0427013, 0427014 and 475 more |
| Model numbers | 450-0005-00, 450-0005-01, 450-0021-00, 450-0021-01, 450-0350, 450-0360, 450-0370, 450-0380, 450-0390, ECOS-450-0005-00, ECOS-450-0021-00 |
Product
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
Reason for recall
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
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-0335-2022. 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.