BiOM Rechargeable Li Ion 22 — Class II medical device recall Z-0467-2013
Terminated recall by iwalk inc, reported 2012-12-12, distributed nationwide. Battery may over-heat during charging and smoke
| Recall number | Z-0467-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | iwalk inc, Bedford, MA, United States |
| Recall initiated | 2012-10-26 |
| Classified | 2012-12-04 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2014-09-26 |
| Distributed | Nationwide (US) |
| Lot numbers | 2973, 48831 |
Product
BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger
Reason for recall
Battery may over-heat during charging and smoke
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-0467-2013. 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.