FDA Medical Device Recalls (openFDA)
Kerr Corporation: 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.
- Recall number
- Z-0402-2013
- Recalling firm
- Kerr Corporation
- 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.
- Status
- Terminated
- Initiated
- 2011-11-17
- Posted
- 2012-11-20
- Terminated
- 2012-11-20
- Reason
- 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
- 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
- 1330 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EBA
- Firm FEI
- 3003848022
- Firm city
- Middleton
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28