Z-0402-2013Class II

Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers...

Name: Z-0402-2013 Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers...
Creator: Kerr Corporation
Published: 2011-11-17
License: https://open.fda.gov/license/

Metrex Research / initiated 2011-11-17 / Terminated / root cause: labeling and UDI

FDA source

Kerr Corporation began a recall of Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length... on 2011-11-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0402-2013
Classification: Class II
Status: Terminated
Initiated: 2011-11-17
Posted: 2012-11-20
Terminated: 2012-11-20
Recalling firm: Metrex Research
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.
Product code: EBA Light, Surgical Headlight
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Orascoptic sent an "URGENT: MEDICAL DEVICE RECALL" letter dated November 17, 2011. The letter identified the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return to the firm. Contact Orascoptic Customer Care at 608-831-2555 for assistance regarding this notice.
Quantity in commerce: 1330 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.
Product codes and lots: 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 has no expiration date. The affected units were produced and distributed since February 2011.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0402-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0402-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-20

Product code EBA

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)