The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0467-2013·Announced 2012-12-12

iwalk BiOM Battery and Charger Recalled for Overheating and Smoke Risk

iwalk inc is recalling BiOM lower leg system batteries and chargers because they may overheat and smoke during charging.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of fire and burn injury due to overheating and smoke, which meets the criteria for a Severe rating (significant injury/property-damage reports or risk).

Plain-English summary

iwalk inc is recalling 21 BiOM Rechargeable Li Ion 22.2 V Batteries (Product Number 2001249, Lot 48831) and 9 BiOM Lithium Battery Chargers (Product Number 2001240, Lot 2973). These products were sold as accessories to the BiOM lower leg system and were distributed nationwide, including in Ohio, North Carolina, and New York.

The recall was initiated because the batteries may overheat during charging and produce smoke. This hazard presents a risk of fire or burn injury to users.

Consumers should stop using the affected batteries and chargers immediately. iwalk inc is the recalling firm responsible for the recall.

The recalled product

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
Manufacturer
iwalk inc
Category
Medical Device — Power Supply / Battery
Hazard

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 (3)

  • Product Code: 2001249 (BiOM Battery)
  • Lot number:48831 Product Code: 2001240 (Charger)
  • Lot number: 2973

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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