Freedom Cordless LED Light System — Class II medical device recall Z-0402-2013
Terminated recall by Kerr Corporation, reported 2012-11-28, distributed nationwide. The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect compo
| Recall number | Z-0402-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kerr Corporation, Middleton, WI, United States |
| Recall initiated | 2011-11-17 |
| Classified | 2012-11-20 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2012-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 1,330 units |
| Serial numbers | 77001000-77003470 |
| Model numbers | 910863-1, 910863-2 |
Product
Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. The device listing number this product is E115952. The intended use of this device is to illuminate oral structures and operating areas.
Reason for recall
The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cause some Freedom Cordless LED Headlight units to become warm to the touch; however, no skin damage will occur.
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-0402-2013. 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.