Z-0467-2013Class II

BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM...

Name: Z-0467-2013 BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM...
Creator: iwalk inc
Published: 2012-10-26
License: https://open.fda.gov/license/

iwalk Inc / initiated 2012-10-26 / Terminated

FDA source

iwalk inc began a recall of 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... on 2012-10-26. FDA classified it as Class II and gives the reason as "Battery may over-heat during charging and smoke". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0467-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-26
Posted: 2012-12-04
Terminated: 2014-09-26
Recalling firm: iwalk Inc
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
Product code: ISW Assembly, Knee/Shank/Ankle/Foot, External
Reason for recall: Battery may over-heat during charging and smoke
FDA root cause: Unknown/Undetermined by firm
Action: iWalk notified customers directly by sales representatives by telephone on October 26, 2012, and instructedthem to stop use of the battery and charger and return them to iWalk. Accounts provided with Return Material Authorizations (RMA). For questions regarding this recall call 781-761-1560.
Quantity in commerce: 21 Batteries; 9 Chargers
Distribution: Nationwide Distribution including OH, NC, and NY.
Product codes and lots: Product Code: 2001249 (BiOM Battery) ,Lot number:48831 Product Code: 2001240 (Charger), Lot number: 2973

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0467-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0467-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-12	2012-12-04

Product code ISW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)